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Updated: Jan 10, 2026
Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
Repeated Intravenous Dosing of Human Umbilical Cord Mesenchymal Stem Cells Improves Glycemic Control and Organ
Sze-Piaw Chin1,2, Erlena Nor Asmira Abd Rahim1, Natasha Najwa Nor Arfuzir1
1Department of Research and Development, Cytopeutics Sdn Bhd, Cyberjaya, Selangor, Malaysia.
Background:
Type-2 diabetes mellitus (T2DM) is a chronic disorder marked by insulin resistance, beta (β)-cell dysfunction, and persistent hyperglycemia, often leading to diabetic kidney disease. There is growing recognition that inflammation exacerbates diabetes. Human umbilical cord mesenchymal stem cells (hUC-MSCs) have shown promising immunomodulatory effects in the treatment of T2DM; however, the optimal dosing remains inconclusive.
Objective:
This study evaluates the effectiveness of early, late, and repeated doses of Cytopeutics® hUC-MSCs in a T2DM rat model.
Methods:
Male Sprague Dawley (SD) rats were allocated into five groups: normal control group and diabetic control group receiving saline, and three diabetic treatment groups receiving hUC-MSCs at different time points-early, late, and repeated. The male rats were fed a high-fat diet (HFD), followed by diabetes induction via a single intraperitoneal injection of streptozotocin (STZ) at 35 mg/kg body weight (BW). Each treatment group received 3.5 × 106 cells/rat intravenously. At the end of the study, blood and tissue were collected before termination for glycemic control (hemoglobin A1C (HbA1c), fasting serum glucose (FSG), and fasting urine glucose (FUG) levels), pro-inflammatory factor high sensitivity C Reactive Protein (hs-CRP), and histopathological analyses.
Results:
The diabetic control group exhibited significantly poorer glycemic control along with extensive pancreatic and kidney damage compared to the normal control group. The early dose group showed limited glycemic control, but reduced hs-CRP sustainably compared to the diabetic control group. The late dose group demonstrated glycemic control partially, and preserved pancreatic β-cells and kidney from damage but did not reduce hs-CRP. The repeated dose group reduced HbA1c, FSG, FUG and hs-CRP up to the end of the study and is also associated with fewer pancreatic β-cells and renal tissue damage.
Conclusion:
Repeated hUC-MSCs administration demonstrated better glycemic control, modulated inflammatory responses, protected β-cells and kidneys from damage in a T2DM rat model.
