By Vivonyx · Last reviewed: October 2026
Our article MSC Therapy for Neuropathy: What the Research Shows gave the big picture: the human research is real, but early. The natural next question is: early how, exactly?
This article opens up the trials themselves: who took part, which cells were used, how they were given, and what was measured. It's education, not medical advice, and it isn't a recommendation for or against anything.
Diabetic neuropathy in two minutes
Peripheral neuropathy is nerve damage that usually affects the feet and legs, and sometimes the hands and arms. It can feel like burning, tingling, numbness, or pain, and it's very common: up to half of people with diabetes have it [1]. Over time, high blood sugar and high blood fats can damage nerves and the small blood vessels that feed them [1].
Researchers note that good glucose control can halt progression in type 1 diabetes, but the effect is more modest in type 2 [2]. Everyday care still centers on managing blood sugar, blood pressure, and cholesterol, checking your feet daily, and, when needed, medicines for nerve pain [1]. Any research option sits alongside that care, not in place of it.
Who was in the trials
The most complete summary so far is a 2024 systematic review and meta-analysis [3]. Out of more than 5,000 records, only seven controlled human studies qualified, with about 400 people in total.
Age: the average participant was about 62 years old [3].
Diabetes type: almost all had type 2 diabetes [3].
Location: six of the seven studies were done in China and one in Egypt [3].
Design: only one was a randomized trial, and the reviewers flagged concerns with how it was randomized and reported [3].
The reviewers themselves named their biggest limitation: a lack of large, high-quality controlled trials, and no trials with long-term follow-up on safety [3].
Which cells were actually used
You might assume these were all mesenchymal stromal cells (MSCs). They weren't.
Five studies used bone marrow mononuclear cells: a same-day mix of many marrow cell types, spun out of the person's own bone marrow [3].
Two studies used umbilical cord-derived MSCs, from donated cord tissue [3].
That matters. MSCs are a specific, lab-defined cell type [4]. A mononuclear cell mix is a different product, with only a small share of MSCs. So most of the human neuropathy data comes from bone marrow cell mixtures, not cultured MSCs. Our comparison Wharton's Jelly vs. Bone Marrow Stem Cells explains these sources in more detail.
How the cells were given
In all but one study, cells were injected into the leg muscles. One study gave them by IV [3].
One trial report describes its method step by step [6]. Participants first received three days of injections of a drug that pushes stem cells out of the marrow. About 200 to 300 mL of marrow was then drawn from the back of the hip under anesthesia in a sterile surgical setting. The processed cells were injected at about 50 sites across both thighs and legs, and patients were monitored in an intensive care unit for at least 24 hours afterward [6].
That's a reminder that "a stem cell injection" in a published trial can mean a substantial hospital procedure.
What the trials measured. Educational summary of the sources cited in this article.
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What the trials measured
The pooled results focused on three kinds of measurements [3]:
Nerve conduction velocity: how fast a signal travels along a nerve, measured with small electrical pulses on the skin.
Vibration perception threshold: how strong a vibration has to be before you can feel it in your feet.
Toronto Clinical Scoring System: a score that combines symptoms such as pain, numbness, and tingling with a simple exam of reflexes and sensation. The maximum score is 19, and lower is better [6].
On average, the pooled results moved in a favorable direction on all three. Nerve signals were about 2 meters per second faster, vibration sense and symptom scores improved, and reported side effects were pain or swelling at the injection sites that went away within a few days [3].
A change on a nerve test is a real, objective measurement. But these studies weren't built to show whether people had less numbness, steadier balance, or fewer foot problems in daily life, and only one was randomized [3].
A closer look at two trials
The largest study enrolled 168 people with diabetic neuropathy that hadn't responded to standard medicines. Everyone received their own bone marrow cells, and results were compared with their own starting measurements, up to 36 months later [5]. The authors reported better symptom scores and nerve tests and no treatment-related adverse events. But with no comparison group, it's hard to separate the cells' effect from other factors, such as closer medical follow-up.
A 2020 "controlled" study of 60 patients used a different kind of control [6]. Its comparison groups were healthy volunteers and people with diabetes but no nerve damage, who didn't receive cells. That isn't a placebo group. When you see "controlled" in a title, check what the control was.
Animal studies vs. people
A companion review pooled 29 animal studies and found promising effects on nerve conduction, nerve blood flow, and pain-related measures, and called for more human studies [7]. Animal results often don't carry over to people.
What about other kinds of neuropathy?
Most of this research is about diabetic neuropathy. For chemotherapy-related neuropathy, a 2020 review described MSC research as a "new challenging approach that requires further investigations," based mainly on experimental studies [8]. Evidence from one type of neuropathy doesn't automatically apply to another.
Where things stand now
FDA status. The FDA says regenerative medicine products, including stem cell and exosome products, have not been approved to treat chronic pain or any neurological disorder, and that there are currently no FDA-approved exosome products [9][10]. Our guide Is Stem Cell Therapy FDA Approved? explains what approval means and what it doesn't.
New trials. One example is a randomized trial in China that plans to enroll about 140 people with moderate to severe diabetic neuropathy, comparing umbilical cord MSCs injected into the muscle with a control group [11]. You can search current studies yourself [12]. One caution from the FDA: a ClinicalTrials.gov listing doesn't, by itself, mean a product is approved or legally marketed [9].
What we still don't know
Whether nerve-test changes mean people feel better in daily life.
How much is placebo. Only one of the seven studies was randomized, so placebo effects are hard to rule out [3].
How long any effect lasts, and long-term safety [3].
Which cell type, dose, or route is best. The studies differed widely [3].
Whether results apply outside the groups studied, mostly older adults with type 2 diabetes in China [3].
Frequently asked questions
How many human trials have tested stem cells for diabetic neuropathy? Not many. A 2024 review found seven controlled human studies with about 400 people in total, and only one was randomized [3].
What kinds of cells were used? Five studies used bone marrow mononuclear cells, a mix of marrow cells from the person's own body. Two used umbilical cord-derived MSCs [3].
How were the cells given? Mostly by injection into the leg muscles. One study used an IV [3]. In one trial, collecting the bone marrow was a hospital procedure under anesthesia [6].
What does nerve conduction velocity mean? It's how fast a signal travels along a nerve. The trials found small average increases, but a faster test result isn't the same as feeling better day to day [3].
Is stem cell therapy FDA-approved for neuropathy? No. The FDA says regenerative medicine products haven't been approved for chronic pain or neurological disorders [9][10].
What questions should I ask about a neuropathy study or offer? Ask what type of cell is used, how it's given, which type of neuropathy was studied, and whether the study was randomized with a comparison group. Our 8 questions worth asking first is a good checklist to bring to your own doctor.
Still have questions?
Neuropathy headlines rarely tell you what was actually tested. If you'd like help with a study, a trial listing, or what to ask next, email hello@vivonyx.com or use our Ask page. We'll give you a straight answer, including "the research doesn't know yet" when that's the truth.
Related reading
Educational disclaimer: This article is for general educational purposes only and is not medical advice, diagnosis, or treatment. It does not describe or suggest the treatment, cure, or prevention of any disease or condition. Regulatory status can change; check the cited FDA pages for current information. Talk with a qualified, licensed healthcare professional before making any medical decision.
References
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Peripheral Neuropathy. https://www.niddk.nih.gov/health-information/diabetes/overview/preventing-problems/nerve-damage-diabetic-neuropathies/peripheral-neuropathy
Feldman EL, Callaghan BC, Pop-Busui R, et al. Diabetic neuropathy. Nat Rev Dis Primers. 2019;5(1):42. PMID: 31197183. https://pubmed.ncbi.nlm.nih.gov/31197183/
Alizadeh SD, Jahani S, Rukerd MRZ, et al. Human studies of the efficacy and safety of stem cells in the treatment of diabetic peripheral neuropathy: a systematic review and meta-analysis. Stem Cell Res Ther. 2024;15(1):442. PMID: 39563393. https://pubmed.ncbi.nlm.nih.gov/39563393/
Dominici M, Le Blanc K, Mueller I, et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315-317. PMID: 16923606. https://pubmed.ncbi.nlm.nih.gov/16923606/
Mao H, Wei W, Fu XL, et al. Efficacy of autologous bone marrow mononuclear cell transplantation therapy in patients with refractory diabetic peripheral neuropathy. Chin Med J (Engl). 2019;132(1):11-16. PMID: 30628954. https://pubmed.ncbi.nlm.nih.gov/30628954/
Wei W, Li L, Deng L, et al. Autologous bone marrow mononuclear cell transplantation therapy improved symptoms in patients with refractory diabetic sensorimotor polyneuropathy via the mechanisms of paracrine and immunomodulation: a controlled study. Cell Transplant. 2020;29:963689720949258. PMID: 32787571. https://pubmed.ncbi.nlm.nih.gov/32787571/
Alizadeh SD, Hassan Zadeh Tabatabaei MS, Rezaei Zadeh Rukerd M, et al. The safety and efficacy of stem cell therapy for diabetic peripheral neuropathy in animal studies: a systematic review and meta-analysis. Neuroscience. 2025;566:49-59. PMID: 39706518. https://pubmed.ncbi.nlm.nih.gov/39706518/
Al-Massri KF, Ahmed LA, El-Abhar HS. Mesenchymal stem cells in chemotherapy-induced peripheral neuropathy: a new challenging approach that requires further investigations. J Tissue Eng Regen Med. 2020;14(1):108-122. PMID: 31677248. https://pubmed.ncbi.nlm.nih.gov/31677248/
U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies
U.S. Food and Drug Administration. Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes
ClinicalTrials.gov. NCT07183761: A randomized controlled trial evaluating the efficacy and safety of intramuscular human umbilical cord mesenchymal stem cell therapy for subjects with moderate to severe diabetic peripheral neuropathy. https://clinicaltrials.gov/study/NCT07183761
ClinicalTrials.gov (U.S. National Library of Medicine). Search: diabetic peripheral neuropathy, stem cell. https://clinicaltrials.gov/search?cond=Diabetic%20Peripheral%20Neuropathy&intr=stem%20cell