What is stem cell therapy?
Stem cell therapy is a broad name for procedures using cells from bone marrow, fat, or umbilical cord blood or tissue. In controlled trials including one each of knee arthritis (480 people) and back pain (404), cell products did not outperform the comparison on the main outcome.[1][2] FDA's statements, with their dates, are in the FDA section of this page.
Overview
Stem cell therapy is a broad name for procedures that inject or infuse cells taken from bone marrow, fat, or umbilical cord blood or tissue. The International Society for Stem Cell Research tells patients: 'Currently, very few stem cell treatments have been proven safe and effective'.[3]
The International Society for Stem Cell Research says: 'The best-defined and most extensively used stem cell treatment is hematopoietic (or blood) stem cell transplantation'.[3]
Three controlled trials, one of 404 people with back pain, one of 565 with heart failure and one of 206 with stroke, tested donor cell products made by companies, and a trial of a manufactured product is not evidence for a product that a clinic prepares itself.[2][4][5]
What is the difference between bone marrow, fat and umbilical cord stem cells?
Bone marrow, fat and umbilical cord stem cell products differ in where the cells come from: bone marrow concentrate and fat-derived cells are taken from the person being treated, and umbilical cord products come from cord blood or cord tissue collected at birth.
Bone marrow aspirate concentrate is made from a person's own bone marrow, which is drawn out and concentrated before it is injected.[6] Stromal vascular fraction is a mix of cells separated from a person's own fat tissue, sometimes described as fat-derived stem cells. Umbilical cord products are made from cord blood or cord tissue collected at birth, and may come from a donor or from a person's own cord blood.[7]
Some cell products are made by companies from donor cells and tested in formal clinical trials, and they are different from the products a clinic prepares on site.
The result column in this table comes from one randomized trial of 480 people with knee osteoarthritis, in which each cell injection was compared with a corticosteroid injection.
| Cell source | Where the cells come from | Result in a 480-person knee trial |
|---|---|---|
| Bone marrow | The person's own bone marrow, drawn out and concentrated[6] | No better than a corticosteroid injection at one year in the main analysis[1] |
| Fat | The person's own fat tissue, processed to separate a mix of cells | No better than a corticosteroid injection at one year in the main analysis[1] |
| Umbilical cord | Cord blood or cord tissue collected at birth, from a donor or from the person's own cord blood[7] | No better than a corticosteroid injection at one year in the main analysis[1] |
In the main analysis of a randomized trial of 480 people with knee osteoarthritis, injections of bone marrow concentrate, fat-derived cells or donor umbilical cord cells were each no better than a corticosteroid injection at one year.[1]
In the main analysis of a randomized trial that compared all three cell sources directly, none gave better results than another at one year.[1] Reviews that rank cell sources by indirect comparison across knee osteoarthritis trials disagree: a 2022 analysis favored stem cells from fat and from umbilical cord over stem cells from bone marrow, and a 2024 analysis of 15 studies with 585 patients favored a person's own bone marrow stem cells for pain and range of motion.[8][9]
The FDA section of this page quotes what FDA has said about stem cell products, with dates.
What is the difference between your own stem cells and donor stem cells?
A person's own stem cells are called autologous, and donor stem cells, which come from another person, are called allogeneic. In two small randomized heart trials that compared a person's own cells with donor cells, the rate of serious adverse events over one year did not differ significantly between the two kinds.[10][11]
The two heart trials enrolled 30 and 37 people with cardiomyopathy, a disease of the heart muscle, gave bone marrow stem cells by injection into the heart, had no placebo group, and in the 37-person trial major cardiac events were less frequent with donor cells than with the person's own cells (p = 0.0186).[10][11] The 37-person heart trial was supported by National Institutes of Health grants, and four of its authors disclosed consulting for a company that develops donor cell products.[11]
A 2022 review of 21 randomized knee osteoarthritis trials with 936 patients found none that compared the two kinds of cells directly, and in its indirect comparison donor cells were followed by more adverse events than control treatments while a person's own cells were not.[12]
The harm reports in this table are single examples, and the table does not show which kind of cell is safer.
| Type of cells | What the term means | Examples in the studies we read | A harm report we read |
|---|---|---|---|
| Your own cells (autologous) | Cells taken from the person being treated | Bone marrow concentrate, fat-derived cells, and blood stem cells returned after chemotherapy | Three people with severe vision loss after injections of their own fat-derived cells into the eyes[13] |
| Donor cells (allogeneic) | Cells taken from another person | Donor umbilical cord products and cell products made by companies from donor bone marrow | 20 people with bacterial infections after receiving contaminated umbilical cord blood products[14] |
Harm has been reported with both kinds of cells: three people lost vision after injections of their own fat-derived cells, and 20 people developed bacterial infections after receiving donor umbilical cord blood products.[13][14]
What the research found
In controlled trials including one each of knee arthritis (480 people), back pain (404), heart failure (565) and stroke (206), stem cell products did not do better than the comparison treatment on the main outcome.[1][2][4][5] In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, we found no published trial of a stem cell product for aging that measured lifespan, biological age or an epigenetic clock.
Our search of ClinicalTrials.gov on October 1, 2026 found registered studies that give a cell product and list an epigenetic measure among their outcomes, including one of cord blood in adults with pre-frailty and two of a person's own cells in Parkinson's disease; none of those three had posted results, and the search also returned studies of blood stem cell transplants for blood cancers, which this page does not cover.[15][16][17]
Evidence levels in this table follow our grading key: Established means consistent results from randomized trials or a systematic review of them, or that a guideline or expert body says something; Emerging means some controlled human evidence that falls short of that, such as small or short trials, mixed results or trials funded by a maker; Evidence against means controlled trials tested the claim on its main result and did not find it, and our searches found no controlled trial that did; and 'no support found' means our search found none. In this table, Not published means our searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026 found no published study for that cell.
| Condition or goal | Who and what was studied | Evidence level | Best source |
|---|---|---|---|
| Knee arthritis | Adults with knee osteoarthritis; bone marrow, fat-derived and umbilical cord cells | Emerging (two reviews disagree; a 480-person randomized trial found no advantage over a corticosteroid injection; a 2019 guideline recommends against) | A 2025 Cochrane review, a 2024 review and a 480-person randomized trial[18][19][1] |
| Back pain | People with chronic low back pain and disc degeneration; donor cell products or the person's own bone marrow cells, injected into spinal discs | Emerging (mixed: trials of 404 and 114 people did not meet their primary outcomes, and trials of a person's own bone marrow cells, of 63 and 52 people, found no significant difference from sham; smaller trials of donor cells reported improvement in pain in some groups, including a 100-person trial with significant differences from control, a 24-person trial in which the improvement seemed restricted to 40% of the cohort, and a 60-person trial in which the high-dose group met its pain endpoint while its low-dose and placebo groups showed nonsignificant improvements; the 100-person and 60-person trials were sponsored and funded by the makers of the products tested, and the published summary of the 24-person trial does not state its funding) | Randomized trials of 404, 114, 100, 63, 60, 52 and 24 people[2][20][21][22][23][24][25] |
| Heart failure | People with heart failure or chronic ischemic heart disease; a donor cell product, or the person's own bone marrow cells | Evidence against for the donor cell product in a trial of 565 people, which did not change its primary endpoint; Emerging for the person's own bone marrow cells (low-quality evidence) | A 565-person randomized trial and a 2016 Cochrane review[4][26] |
| Stroke | People who had an ischemic stroke; several kinds of cells | Emerging (mixed: small trials lean positive on an impairment scale; a 206-person placebo-controlled trial found no difference) | A 2019 Cochrane review and a 206-person randomized trial[27][5] |
| Multiple sclerosis, cell infusions | People with active or progressive multiple sclerosis; their own mesenchymal stem cells | Emerging (mixed: randomized trials of 144, 54 and 18 people found no significant difference on their primary endpoints; a sham-controlled trial of 48 people reported fewer treatment failures with the cells, and its published summary does not state its funding) | Randomized trials of 144, 54, 48 and 18 people[28][29][30][31] |
| Multiple sclerosis, transplant after chemotherapy | People with relapsing-remitting multiple sclerosis and relapses while on drug therapy, and, in a 21-person trial, people with worsening relapsing-remitting or secondary progressive disease; chemotherapy followed by their own blood stem cells | Emerging (a randomized trial enrolled 110 people, and a 21-person randomized trial was read as a published summary; other randomized trials that compare the transplant with drug therapy are registered on ClinicalTrials.gov, including two that plan 156 and 100 people and had not reported results as of October 1, 2026; a pooled estimate of 2.1% transplant-related deaths) | Randomized trials of 110 and 21 people and a 2017 pooled analysis of 15 studies[32][33][34] |
| COPD | People with moderate to severe COPD; a donor cell product | Emerging (small trials; no significant change in lung function tests in the trial and review we read) | A 62-person randomized trial and a 2022 review of 11 studies[35][36] |
| Autism | Children aged 2 to 12 with autism; cells from cord blood or cord tissue | For cord blood and cord tissue cells: Evidence against for a single infusion (a trial of 180 children, a 29-child crossover trial, and results posted on ClinicalTrials.gov for a 137-child trial found no significant difference from placebo on their main measures); Emerging for repeated infusions (a 34-child randomized trial at one center and a 37-child trial that was not randomized reported better scores). Trials of bone marrow cells are described in the text. | Placebo-controlled randomized trials of 180, 34 and 29 children, registry results from a 137-child trial, a 37-child trial that was not randomized, and a 2022 review of 5 studies[7][37][38][39][40][41] |
| Frailty in older adults | Frail older adults; donor cell products given into a vein | Emerging (small trials, trials linked to the product's maker or a trial without a placebo group; the trials reported walking, physical performance and quality-of-life scores, and some also reported blood markers of inflammation or immune function) | Randomized trials of 30, 30, 148 and 147 people[42][43][44][45] |
| Slowing aging or extending life | Not published | No support found (searches of PubMed, Europe PMC and ClinicalTrials.gov, October 1, 2026) | Our searches of PubMed, Europe PMC and ClinicalTrials.gov for published trials of stem cell products for aging that measured lifespan, biological age or an epigenetic clock |
| Hair loss | People with non-scarring hair loss; fat-derived cells | Emerging (small studies; 3 of 6 were randomized trials) | A 2022 systematic review of 6 studies[46] |
What FDA has said about stem cell products is quoted, with dates, in the FDA section of this page.
What does research show about stem cell injections for knee arthritis?
For knee osteoarthritis, two reviews of randomized trials reached different conclusions about stem cell injections: a 2025 Cochrane review found they may slightly improve pain and function compared with a placebo injection, based on low-certainty evidence, and a 2024 review concluded they probably provide little to no improvement.[18][19] The Cochrane knee review lowered its certainty rating partly because of suspected publication bias, noting that up to three larger trials had been conducted but withdrawn before their results were reported.[18]
The 2025 Cochrane review of stem cell injections for knee osteoarthritis included 25 randomized trials with 1,341 participants.[18] In the 7 studies (445 participants) in the Cochrane review that compared knee pain with a placebo injection, pain averaged 4.5 points out of 10 with placebo and was 1.2 points better with a stem cell injection up to six months after treatment, with a range from 2.5 points better to no difference, which the review rated low-certainty evidence.[18]
None of the trials in the Cochrane knee review measured whether arthritis progressed on X-ray, and the review's authors wrote that they 'remain uncertain of the effect of stem cell injections on structural progression in the knee'.[18] A 2026 review that included 28 randomized trials of stem cell injections for knee osteoarthritis reported that pooled MRI scores of the joint showed no significant difference, 'indicating no consistent structural benefit'; its published summary does not say how many of the trials measured MRI and gives no certainty rating.[47] A 2023 review of 9 studies of stem cell implantation for knee osteoarthritis reported improved cartilage on MRI in the 5 studies that used it, and its authors said the evidence is limited because the studies differed widely and too few had a control group.[48]
A 2024 systematic review of 16 randomized trials with 807 participants concluded that mesenchymal stem cell injections for chronic knee pain from osteoarthritis probably provide little to no improvement in pain or physical function.[19]
In a randomized trial, 480 people with knee osteoarthritis were assigned to an injection of bone marrow concentrate, fat-derived cells, donor umbilical cord cells or a corticosteroid.[1] At one year, in the 440 people included in the 480-person knee trial's main analysis, none of the three cell injections was better than the corticosteroid injection or than the other cell injections.[1] A separate secondary analysis of 381 people from the same knee trial who completed 12 months of follow-up, which sorted people into responders and non-responders on a pain scale, reported higher odds of responding with bone marrow concentrate than with the corticosteroid injection (adjusted odds ratio 2.02, 95% confidence interval 1.09 to 3.76), while the trial's main analysis found no significant difference between groups.[49] The 480-person knee trial was funded by a foundation, and its authors disclosed that the health system employing several of them has a financial interest in the company that made the fat-derived product.[1] In the 480-person knee trial, none of the four groups showed a significant change from the start of the study in an MRI score of knee osteoarthritis.[1]
No procedure-related serious adverse events were reported during the 480-person knee trial.[1] Among the 440 people treated in the 480-person knee trial, joint swelling was reported in 24.1% of those given donor umbilical cord cells, 17.8% of those given their own bone marrow concentrate, 14.7% of those given their own fat-derived cells and 7.4% of those given a corticosteroid.[1]
In a small placebo-controlled trial, 25 people with osteoarthritis in both knees had bone marrow concentrate injected into one knee and saline into the other, and over 6 months pain relief did not differ significantly between the two knees.[6]
The 2019 American College of Rheumatology and Arthritis Foundation guideline strongly recommends against stem cell injections for people with knee or hip osteoarthritis; the guideline predates the newer trials and reviews published from 2023 to 2025.[50] The 2019 American College of Rheumatology and Arthritis Foundation guideline cites 'concern regarding the heterogeneity and lack of standardization in available preparations of stem cell injections, as well as techniques used'.[50]
On its page 'Important Patient and Consumer Information About Regenerative Medicine Therapies' (dated June 3, 2021; FDA page content current as of April 8, 2024), FDA says: "Regenerative medicine therapies have not been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain."
What does research show about stem cells after a stroke?
A 2019 Cochrane review found that stem cell transplantation after ischemic stroke was associated with a better score on a neurological impairment scale (5 studies, 319 participants, low-certainty evidence) but not with a better score on a disability scale (6 studies, 371 participants, very low-certainty evidence).[27] The Cochrane stroke review noted that the studies favoring stem cell transplantation had, on average, a higher risk of bias and 32 or fewer participants.[27]
In a placebo-controlled trial of 206 people in Japan treated 18 to 36 hours after an ischemic stroke, a donor cell product given into a vein made no difference to the primary or secondary outcomes, and the trial was funded by its commercial sponsor.[5] A 2024 review that pooled 15 randomized and 15 non-randomized trials with 1,217 patients reported better disability and impairment scores with mesenchymal stem cells in the randomized trials; its published summary gives no certainty rating, and we have not read the full review.[51]
On its page 'Important Patient and Consumer Information About Regenerative Medicine Therapies' (dated June 3, 2021; FDA page content current as of April 8, 2024), FDA says: "Regenerative medicine therapies have not been approved to treat any neurological disorder, such as multiple sclerosis, amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease), Alzheimer's disease, Parkinson's disease, epilepsy, or stroke."
What does research show about stem cells for multiple sclerosis?
Research on stem cells for multiple sclerosis covers two different procedures: infusions or injections of mesenchymal stem cells, where randomized trials have given mixed results, and a chemotherapy-based transplant of a person's own blood stem cells, where a randomized trial enrolled 110 people.
Stem cell infusions for multiple sclerosis
In a randomized, placebo-controlled crossover trial of 144 people aged 18 to 50 with active multiple sclerosis, infusions of the person's own bone marrow mesenchymal stem cells did not meet the primary endpoint, the number of gadolinium-enhancing lesions on MRI, a marker of acute inflammation, counted at weeks 4, 12 and 24.[28] The authors of the 144-person multiple sclerosis trial concluded that the 'study does not support the use of bone marrow-derived MSCs to treat active multiple sclerosis'.[28]
In a small placebo-controlled trial of 18 people with progressive multiple sclerosis, the person's own mesenchymal stem cells injected into the spinal fluid produced no significant difference on the primary endpoint.[31] In the 18-person multiple sclerosis trial, one serious adverse event was judged probably related to the cell injection, fever and low back pain followed the injection in 9 and 10 people, 7 people had abnormalities on spinal MRI at 6 months, and one person developed chronic pain at the base of the spine attributed to arachnoiditis.[31] The authors of the 18-person trial wrote that the adverse events suggest 'an acute localized inflammatory reaction' after the injection, and they advised caution in future studies of stem cell injections into the spinal fluid.[31]
In a placebo-controlled randomized trial at one center, 54 people with progressive multiple sclerosis had six injections into the spinal fluid of a cell product made from their own bone marrow stem cells or of saline, and the share who improved on the primary outcome, a combined measure of disability, walking speed and hand function, did not differ (33% with the cells and 37% with saline); the trial lists a multiple sclerosis society and a drug company as funders.[29]
In a sham-controlled randomized trial of 48 people with active progressive multiple sclerosis, the authors reported treatment failure in 6.7% of people given their own mesenchymal stem cells into the spinal fluid and 9.7% of those given them into a vein, against 41.9% of those given sham injections, and they called for a larger trial to confirm the findings; we read the published summary only, and it does not state the trial's funding.[30]
Other small randomized trials of mesenchymal stem cells in multiple sclerosis appeared in our searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026; we have not read them in full, and this page does not report their results.
On its page 'Important Patient and Consumer Information About Regenerative Medicine Therapies' (dated June 3, 2021; FDA page content current as of April 8, 2024), FDA says: "Regenerative medicine therapies have not been approved to treat any neurological disorder, such as multiple sclerosis, amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease), Alzheimer's disease, Parkinson's disease, epilepsy, or stroke."
Chemotherapy-based transplant for multiple sclerosis
Autologous hematopoietic stem cell transplantation for multiple sclerosis uses chemotherapy and other immune-suppressing drugs, followed by a transplant of the person's own blood stem cells.[32][34]
In a randomized trial of the transplant, 110 people with relapsing-remitting multiple sclerosis who had at least 2 relapses in the prior year while on drug therapy were assigned to the transplant or to continued drug therapy, and disease progression occurred in 3 people in the transplant group and 34 in the drug therapy group.[32] The authors of the 110-person transplant trial called it a preliminary study; it ran at 4 centers, the neurologists who scored disability, the measure used to define disease progression, did not know which treatment each person had received, and the doctors who recorded relapses did know.[32] The 110-person transplant trial reported financial support from a family, two foundations, a financial firm and a public research facility in the United Kingdom, and its authors stated that it had no industry or pharmaceutical support.[32]
A smaller randomized trial, published in 2015, assigned 21 people with relapsing-remitting or secondary progressive multiple sclerosis that had worsened in the past year to the transplant or to the drug mitoxantrone, and its authors reported 79% fewer new lesions on MRI over 4 years with the transplant, the trial's primary endpoint, and no difference in the progression of disability; we read the published summary only, and it does not state the trial's funding.[33]
Other randomized trials that compare the transplant with drug therapy are registered on ClinicalTrials.gov, including NCT04047628, which plans 156 people, and NCT03477500, which plans 100; neither had posted results there as of October 1, 2026, and a PubMed search by registry number on that date found no published results for either.[52][53] Another registered randomized study, NCT03342638, compared two versions of the transplant with each other in 66 people, was stopped early and has results posted on ClinicalTrials.gov that we have not read.[54]
A 2017 pooled analysis of 15 studies and 764 people who had autologous hematopoietic stem cell transplantation for multiple sclerosis estimated that 2.1% died from causes related to the transplant (95% confidence interval 1.3% to 3.4%).[34]
Results from the chemotherapy-based transplant do not apply to stem cell infusions, and results from stem cell infusions do not apply to the transplant.
What does research show about stem cells for COPD?
The controlled evidence on stem cell products for COPD that we read comes from small trials, and those trials found no significant improvement in lung function tests.[35][36] In a randomized, placebo-controlled trial of 62 people with moderate to severe COPD, four monthly infusions of a donor cell product produced no significant differences in lung function tests or quality-of-life measures.[35]
A 2022 review that pooled 11 studies with 371 people with COPD found no statistically significant change in a standard lung function measure and a longer six-minute walk distance, in comparisons made against either a control group or the patients' own starting values.[36]
On its page 'Important Patient and Consumer Information About Regenerative Medicine Therapies' (dated June 3, 2021; FDA page content current as of April 8, 2024), FDA says: "Regenerative medicine therapies have not been approved for the treatment of any cardiovascular or pulmonary (lung) diseases, such as heart disease, emphysema, or chronic obstructive pulmonary disease (COPD)."
What does research show about stem cells for autism?
Most of the trials of stem cell products for autism that we read tested cord blood infusions in children. In a randomized, placebo-controlled trial of 180 children aged 2 to 7 with autism, a single infusion of cord blood was not associated with better socialization skills or fewer autism symptoms across the whole group.[7]
Findings in a subgroup of children without intellectual disability in the 180-child autism trial were exploratory and do not change the trial's main result.[7]
A smaller randomized, placebo-controlled crossover trial gave 29 children aged 2 to 6 with autism an infusion of their own cord blood and found no statistically significant difference on any of its measures; the study was funded by a company, from which its lead author had received consulting and speaking fees.[38]
In a separate trial at one center, 34 children aged 3 to 8 with autism and signs of immune dysregulation received four infusions of donor cord blood cells or placebo, and at 13 weeks the cord blood group had a greater reduction on a social responsiveness scale (P = 0.045).[37] In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, we found no second published trial of cord blood cells that enrolled children with autism on the basis of immune dysregulation; several registered studies of cord blood cells in autism that were not randomized give immune problems as part of their rationale, including NCT03786744[55] (20 children, completed, results posted that we have not read), NCT01343511[56] (37 children, completed and published in 2013) and NCT04099381[57] (150 children planned, status unknown, no posted results), and none of these three lists an immune measure among its entry criteria.
Randomized trials have also given children with autism their own bone marrow cells by injection into the spinal fluid: one, of 32 children aged 5 to 15 and funded by a medical university, found no significant difference from usual treatment on two autism rating scales or a clinician's improvement score over 12 months, while a clinician's severity score improved more in the cell group, and an open-label trial of 54 children aged 3 to 7, whose record lists a company as funder, reported better scores on autism severity and adaptive behavior scales at 12 months than education alone.[58][59]
A 2022 review of 5 studies reported lower autism rating scores with stem cell therapy than with rehabilitation alone and no difference on a clinician's overall impression score, and its authors said the evidence was limited by small study sizes.[41]
On its page 'Important Patient and Consumer Information About Regenerative Medicine Therapies' (dated June 3, 2021; FDA page content current as of April 8, 2024), FDA says: "Regenerative medicine therapies have not been approved to treat autism, macular degeneration, blindness, chronic pain, or fatigue."
What has FDA said about stem cell products?
FDA's list of licensed cell and gene therapy products includes cord blood products and Ryoncil (checked September 30, 2026).
On December 18, 2024, FDA announced its approval of Ryoncil (remestemcel-L-rknd), "an allogeneic (donor) bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients 2 months of age and older." FDA called Ryoncil "the first FDA-approved MSC therapy."
FDA's announcement also said: "Complications such as hypersensitivity and acute infusion reactions, transmission of infectious disease or agents and ectopic tissue formation may occur following treatment with Ryoncil."
FDA's list of licensed products (FDA page content current as of September 17, 2026) includes several cord blood products. FDA's page for one of them, HEMACORD (HPC, cord blood), gives its use as "For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment." (FDA page content current as of April 24, 2019.)
The prescribing information for HEMACORD (HPC, Cord Blood) carries a boxed warning about fatal infusion reactions, graft versus host disease, engraftment syndrome and graft failure.
Sources: HEMACORD (HPC, Cord Blood) injectable suspension prescribing information, Revised 4/2013.
On its page 'Important Patient and Consumer Information About Regenerative Medicine Therapies' (dated June 3, 2021; FDA page content current as of April 8, 2024), FDA says: "These unapproved products whether recovered from your own body or another person's body, include stem cells, stromal vascular fraction (fat-derived cells), umbilical cord blood and/or cord blood stem cells", and the list continues: "amniotic fluid, Wharton's jelly, ortho-biologics, and exosomes." FDA attaches a footnote to "cord blood stem cells" that reads: "Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood (i.e., the 'hematopoietic' system) but they are not approved for other uses." That page predates FDA's December 18, 2024 approval of Ryoncil, a mesenchymal stromal cell therapy.
On its page 'Important Patient and Consumer Information About Regenerative Medicine Therapies' (dated June 3, 2021; FDA page content current as of April 8, 2024), FDA says: "Please know that if you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally."
Regulatory status checked September 30, 2026. Sources: www.fda.gov/…/approved-cellular-and-gene-therapy-products; www.fda.gov/…/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host; www.fda.gov/…/download; www.fda.gov/…/ryoncil; www.fda.gov/…/download; www.fda.gov/…/hemacord-hpc-cord-blood; www.fda.gov/…/download; www.fda.gov/…/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes; www.fda.gov/…/important-patient-and-consumer-information-about-regenerative-medicine-therapies; www.fda.gov/…/patient-and-consumer-warning-about-potential-serious-risks-harm-following-use-unapproved-products
What are the risks of stem cell therapy?
Reports of harm from stem cell products come from published case reports, public health investigations, clinical trials and treatment registries kept by clinics. The International Society for Stem Cell Research tells patients: 'Cells from your own body are not automatically safe when used in treatments'.[3]
Trials report how often side effects happened among their own participants, and the two treatment registry reports on how often harm happened among people treated outside trials that we cite on this page were written, wherever the record let us tell, by authors who include people who own or work for the clinic or company that gave the treatment.
Three women aged 72, 78 and 88 with macular degeneration had severe vision loss in both eyes after a United States clinic injected fat-derived cells from their own bodies into their eyes, and a year later their vision ranged from 20/200 to no light perception.[13] The doctors who reported the three vision loss cases wrote that the patients 'paid for a procedure that had never been studied in a clinical trial, lacked sufficient safety data, and was performed in both eyes on the same day'.[13]
A public health investigation published in 2021 confirmed bacterial infections in 20 people from 8 states, aged 2 to 89, who had received umbilical cord blood products marketed as stem cell therapy for pain, osteoarthritis, rheumatoid arthritis or injury, and all but one needed hospital care.[14] When investigators tested unopened vials of the umbilical cord blood products, 22 of 34 were contaminated with bacteria.[14]
A 2024 CDC report described three people from the United States who developed infections with Mycobacterium abscessus, a drug-resistant bacterium, after stem cell injections at clinics in Mexico in 2022.[60]
A 2009 case report described a boy with a rare inherited disease who was diagnosed with a brain tumor four years after injections of fetal neural stem cells, a different cell type from bone marrow, fat or umbilical cord products, and tests showed the tumor did not come from the boy's own cells.[61]
A 2024 systematic review of randomized trials rated as low-certainty its findings that mesenchymal stem cell injections into the knee may increase side effects of any kind and may increase pain and swelling in the joint.[19]
The 2025 Cochrane knee review counted serious adverse events in 4 of 242 people given stem cell injections and 5 of 219 given placebo (7 trials, 461 participants), rated that evidence very low certainty because it was indirect, imprecise and possibly affected by publication bias, and said the possible harms of stem cell injections remain uncertain.[18]
A 2026 review that included 28 randomized knee osteoarthritis trials reported injection-site pain and joint swelling more often after stem cell injections than after control treatments (risk ratios 2.04 and 3.39), and described serious complications such as infection as 'uncommon and non-significant'.[47]
A treatment registry covering 18 clinics recorded 325 adverse events among 2,372 people given injections of their own cells for orthopedic conditions between 2005 and 2014, most often pain after the procedure (93 people, 3.9%); the events were recorded in the treating clinics' own registry.[62] In the same registry report, seven people reported new tumors, which the authors described as a lower rate than in the general population.[62]
A second registry report counted 20 cases of blood clots in veins after 12,780 bone marrow concentrate treatments of the knee at 72 clinics from 2007 to 2020 (0.16%), and four of its five authors disclosed being employees, an officer or a shareholder of one company.[63]
The authors of a 2020 survey of academic neurologists reported 'an alarming list of unreported complications' from unproven stem cell procedures and called for a national registry to record them.[64]
On its page 'Important Patient and Consumer Information About Regenerative Medicine Therapies' (dated June 3, 2021; FDA page content current as of April 8, 2024), FDA says: "FDA has received reports of blindness, tumor formation, infections, and more, detailed below, due to the use of these unapproved products."
On its page 'Patient and Consumer Warning about Potential Serious Risks of Harm following Use of Unapproved Products from Human Cells or Tissues' (FDA page content current as of May 11, 2026), FDA says it "continues to receive complaints or reports of adverse events involving such products, including patient deaths following their use." FDA describes one report of a patient who died after injecting Laennec, "an imported human placental tissue-derived product that FDA has not approved," and adds: "Although the testing did not isolate the pathogen associated with the patient's death, FDA remains concerned about such products."
Anyone with a medical condition should talk with a licensed clinician before deciding on any stem cell product.
If you have severe symptoms, call 911 or seek emergency care. Report side effects to FDA MedWatch.
How can you tell a clinical trial from a paid stem cell treatment?
The International Society for Stem Cell Research tells patients: 'An experimental treatment offered for sale is not the same as a clinical trial'.[3] The International Society for Stem Cell Research says: 'Patient testimonials and other marketing provided by clinics may be misleading'.[3]
One of the three women who lost vision after stem cell eye injections told the researchers she had found the clinic through its listing on ClinicalTrials.gov, a registry of studies, and the written information she was given did not mention taking part in a clinical trial.[13] The study that the clinic in the vision loss cases had listed on ClinicalTrials.gov was withdrawn before enrollment began.[13]
The FDA section of this page quotes what FDA has said about stem cell products, with dates.
FAQs
What does research show about stem cell injections for knee arthritis?
For knee osteoarthritis, two reviews of randomized trials reached different conclusions about stem cell injections: a 2025 Cochrane review found they may slightly improve pain and function compared with a placebo injection, based on low-certainty evidence, and a 2024 review concluded they probably provide little to no improvement. The Cochrane knee review lowered its certainty rating partly because of suspected publication bias, noting that up to three larger trials had been conducted but withdrawn before their results were reported. In the main analysis of a randomized trial of 480 people with knee osteoarthritis, injections of bone marrow concentrate, fat-derived cells or donor umbilical cord cells were each no better than a corticosteroid injection at one year. A separate secondary analysis of 381 people from the same knee trial who completed 12 months of follow-up, which sorted people into responders and non-responders on a pain scale, reported higher odds of responding with bone marrow concentrate than with the corticosteroid injection (adjusted odds ratio 2.02, 95% confidence interval 1.09 to 3.76), while the trial's main analysis found no significant difference between groups. The 2019 American College of Rheumatology and Arthritis Foundation guideline strongly recommends against stem cell injections for people with knee or hip osteoarthritis; the guideline predates the newer trials and reviews published from 2023 to 2025.
What does research show about stem cell injections for back pain?
For chronic low back pain, controlled trials of 404 and 114 people that injected donor cells into spinal discs did not meet their primary outcome. Smaller randomized trials of donor cells injected into discs reported improvement in pain in some groups of patients. Among them, a 100-person trial reported significant differences between its control groups and its cell groups in pain and disability scores; a 24-person trial with a sham injection as the control reported a significant improvement in pain and function scores versus the controls, and its authors wrote that the improvement seemed restricted to a group of responders that included 40% of the cohort; and in a 60-person trial with four groups, the high-dose group's pain score fell 62.8% from its own baseline at 52 weeks and met the primary endpoint of a reduction of more than 30%, the group given the carrier fluid alone had a smaller significant reduction, and the low-dose and placebo groups showed nonsignificant improvements. The 100-person and 60-person trials were sponsored and funded by the makers of the products tested, and the published summary of the 24-person trial does not state its funding.
In a sham-controlled randomized trial of 52 people with chronic low back pain and disc degeneration at up to three levels, funded by Italy's health ministry, pain, disability and quality-of-life scores improved similarly over 6 months in people given their own bone marrow mesenchymal stem cells and in those given the sham procedure, with no significant difference between the groups; its authors call the report preliminary. In a randomized trial of 114 people with chronic low back pain, 74% of those given donor bone marrow cells and 69% of those given a sham injection met the trial's definition of improvement at 12 months, a difference that was not statistically significant. The 114-person back pain trial was funded by French and European Union public research programs.
In a randomized trial of 404 people with chronic low back pain and moderate disc degeneration, a donor cell product did not reach significance on the primary endpoint compared with the control injection, and the trial was sponsored and funded by the product's maker. The positive findings reported by the authors of the 404-person back pain trial came from a subgroup and from other analyses, and none of the trial's secondary endpoints showed a significant difference across all participants.
In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, we found no published sham-controlled or placebo-controlled trial of fat-derived cells injected for back pain, and the registered studies of fat-derived cells for disc disease that the searches returned had no sham or placebo group.
In a sham-controlled randomized trial of a person's own bone marrow concentrate for back pain, 63 people with disc-related low back pain had a single injection into the disc or a sham procedure, and the share with at least 50% pain relief did not differ significantly at 3, 6 or 12 months (44% with the injection and 56% with the sham at 12 months). The authors of the 63-person back pain trial wrote that its limitations, including no quality analysis of the cells injected, limit what can be concluded about bone marrow concentrate injected into discs.
On its page 'Important Patient and Consumer Information About Regenerative Medicine Therapies' (dated June 3, 2021; FDA page content current as of April 8, 2024), FDA says: "Regenerative medicine therapies have not been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain."
What does research show about stem cells for heart failure?
In a randomized, sham-controlled trial of 565 people with heart failure, a donor cell product injected into the heart muscle did not change the primary endpoint, and the trial was supported by the product's maker. The authors of the 565-person heart failure trial reported signals of benefit in prespecified and post hoc analyses, and the trial's primary and secondary endpoints were negative. A 2016 Cochrane review found low-quality evidence, from 9 trials with 491 participants, of fewer deaths at 12 months or later with bone marrow cell therapy in people with chronic ischemic heart disease and heart failure; its authors urged caution because few events occurred, one of them had led four of the included studies, the published summary we read does not state the review's funding, and the finding is about people with those heart conditions only. The 565-person heart failure trial tested a donor cell product made by a company, and its result is not evidence about bone marrow or fat-derived cells prepared by a clinic.
On its page 'Important Patient and Consumer Information About Regenerative Medicine Therapies' (dated June 3, 2021; FDA page content current as of April 8, 2024), FDA says: "Regenerative medicine therapies have not been approved for the treatment of any cardiovascular or pulmonary (lung) diseases, such as heart disease, emphysema, or chronic obstructive pulmonary disease (COPD)."
What does research show about stem cell therapy for aging and frailty?
In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, we found no published trial of a stem cell product for aging that measured lifespan, biological age or an epigenetic clock.
The frailty trials of stem cell products that we read reported walking, physical performance or quality-of-life scores in frail older adults, some also reported blood markers of inflammation or immune function and one a lung function measure, and none reported lifespan or biological age as an outcome in the text we read. In a 2026 trial of 148 people with frailty, the first part of the primary endpoint, the change in six-minute walk distance for an individual dose compared with placebo at six months, was numerically better without reaching statistical significance, and a prespecified dose-response analysis was statistically significant. The 148-person frailty trial was funded by a National Institutes of Health grant awarded to the product's maker, and its senior author is the maker's chief scientific officer and holds equity in the company.
In a randomized, placebo-controlled trial of 30 people with frailty at one hospital in China, the authors reported a larger improvement in a physical quality-of-life score, the trial's primary measure, at six months after two monthly infusions of donor umbilical cord cells than after placebo (p = 0.042); a timed stand-and-walk test and grip strength also favored the cell group, and a 4-meter walking test did not differ significantly (p = 0.21). The 30-person frailty trial was funded by Chinese public research programs, and its authors declared no competing interests.
Studies in animals do not show whether stem cell products slow aging in people. FDA's statements about stem cell products are quoted, with dates, in the FDA section of this page.
What does research show about stem cell injections for hair loss?
A 2022 systematic review of fat-derived cell injections for non-scarring hair loss found 6 studies with 188 patients, 3 of them randomized trials, and every study reported better hair density than a control or than the patients' own starting point. The hair loss review counted improvement against either a control group or the patient's own starting point, and its published summary gives no certainty rating. Several of the other hair studies our searches returned tested cell-free products, such as exosomes or the liquid in which cells were grown, which are different from cell injections. For FDA's own words and their dates, see the FDA section of this page.
What are the risks of stem cell therapy?
Reports of harm from stem cell products come from published case reports, public health investigations, clinical trials and treatment registries kept by clinics. Trials report how often side effects happened among their own participants, and the two treatment registry reports on how often harm happened among people treated outside trials that we cite on this page were written, wherever the record let us tell, by authors who include people who own or work for the clinic or company that gave the treatment. Three women aged 72, 78 and 88 with macular degeneration had severe vision loss in both eyes after a United States clinic injected fat-derived cells from their own bodies into their eyes, and a year later their vision ranged from 20/200 to no light perception. A public health investigation published in 2021 confirmed bacterial infections in 20 people from 8 states, aged 2 to 89, who had received umbilical cord blood products marketed as stem cell therapy for pain, osteoarthritis, rheumatoid arthritis or injury, and all but one needed hospital care. When investigators tested unopened vials of the umbilical cord blood products, 22 of 34 were contaminated with bacteria. The International Society for Stem Cell Research tells patients: 'Cells from your own body are not automatically safe when used in treatments'.
References
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