Peripheral neuropathy is damage to the nerves that run from the spinal cord to the hands, feet and body. Researchers study it most often in diabetes, after chemotherapy, and in inherited forms such as Charcot-Marie-Tooth disease. The studies below use a shared vocabulary. Mesenchymal stem cells are defined by a consensus set of laboratory criteria [13]. The studies below measure nerve conduction speed, the density of small nerve fibers in a skin sample, and pain scores [1] [4] [7].
Human studies: what the reviews pooled
A 2024 systematic review and meta-analysis pooled seven controlled human trials of stem cell therapy for diabetic peripheral neuropathy [1]. It found faster motor and sensory nerve conduction, and a lower Toronto Clinical Scoring System score (weighted mean difference -3.6) [1]. The reported complications were pain and swelling at the injection site, which resolved within a few days [1].
A 2025 meta-analysis pooled pain studies across diabetic neuropathy, osteoarthritis and spinal cord injury [4]. It reported a mean difference of -2.58 on the visual analog pain scale at six months, lower in the stem cell groups [4]. Pooled results across three conditions are hard to apply to one of them, and the authors call for larger studies [4].
Randomized trials: small and mixed
- A phase 2 randomized, placebo-controlled trial of 26 people with diabetic neuropathy tested two doses of a mesenchymal-like cell product against placebo [7]. The primary measure was nerve fiber density in a skin sample at six months [7]. It showed no significant change, and both doses were well tolerated [7].
- A pilot randomized study in type 1 diabetes randomized 42 people and followed 29 of them for eight years [8]. Chronic diabetic complications were the primary endpoint, and peripheral neuropathy developed in 1 of 14 treated people and 7 of 15 controls (P = 0.017) [8]. The study was open-label [8].
- A phase 1 study gave nine people with Charcot-Marie-Tooth disease type 1 a single injection of a Schwann-cell-like product derived from tonsil mesenchymal stem cells [9]. No drug-related serious adverse events or dose-limiting toxicities occurred, and exploratory scores improved by week 24 [9]. A phase 1 study measures safety first, so it does not show whether the product works [9].
Animal and laboratory evidence
Animal evidence is larger [2] [3]. A review of 29 animal studies found that stem cells improved nerve conduction, with dental pulp cells showing the largest effects in subgroup analysis [2]. A meta-analysis of 23 preclinical studies reported large standardized effects on nerve conduction and fiber density [3]. A review of 25 animal studies of neuropathic pain found pain reduction in 23 of them, and reduced inflammation was linked to pain relief [5]. Animal results often do not carry over to people, which is why the human trials matter most. A systematic review of human stem cell-derived nerve cell models of chemotherapy-induced neuropathy found that most model checks relied on acute drug effects in the laboratory, and it proposed changes to make those models more relevant [6].
Registered trials
Three further registered studies cited here concern stem cells and neuropathy, besides the eight-year trial above [10][11][12]. One recruiting randomized trial plans 140 participants with three umbilical cord cell injections [10]. One study, with status listed as unknown, planned 42 participants [11]. One was withdrawn before enrolling anyone [12]. None of the three has posted results [10][11][12].
How to read a neuropathy study
- The design. Was the study randomized, and was it blinded? What did the comparison group receive?
- The size. Seven trials pooled in one review is not the same evidence as one large trial [1].
- The measure. Nerve conduction, nerve fiber density and pain scores measure different things [1] [4].
- The cells. Check the cell source and how the cells were prepared, which the methods section of each study describes.
Where to find the studies
Search stem cell studies of peripheral neuropathy on ClinicalTrials.gov to see registered designs and status. Search systematic reviews of stem cells and neuropathy on PubMed for published reviews. The knee guide covers stem cell research and the knee, a joint studied with a similar design. This guide reports research only. It does not describe what treatment at GIOSTAR will do. For how GIOSTAR's stem cell service works, see stem cell therapy.
Regulatory Status
A 2026 review of FDA regulation of biologics examines how that oversight applies to stem cell products [14]. Our stem cell therapy is not approved by the FDA.
