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Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
Effect of Mesenchymal Stem Cell Infusion in Stage II-IV Diabetic Nephropathy
Sohail Sabir, Mohsin Shahzad1, Umair Ijaz Malik
1Department of Nephrology, Pak Emirates Military Hospital, Rawalpindi, Pakistan.
Objective:
To compare the effect of mesenchymal stem cell (MSC) infusion vs. placebo on glomerular filtration rate (GFR) in patients with stage II-IV diabetic nephropathy.
Study Design:
A randomised controlled trial. Place and Duration of the Study: Department of Nephrology, Pak Emirates Military Hospital, Rawalpindi, Pakistan, from December 2022 to May 2025.
Methodology:
Patients with diabetic kidney disease (DKD, stage II-IV) were selected and randomly assigned to either the intervention or placebo group. The study was conducted in a double-blinded manner after obtaining written consent. Baseline data, including age, gender, use of ACE inhibitors, ARBs, or SGLT2 inhibitors, and duration of disease, were recorded. Relevant diagnostic data, including complete blood counts, serum creatinine, serum urea, potassium, uric acid, glycosylated haemoglobin, spot urine albumin-to-creatinine ratio, routine urine examination, and kidney-ureter-bladder (KUB) ultrasound, were collected using a study proforma. DTPA (nuclear renal) scans were performed at baseline and at six months. Interquartile range (quantitative variables) and frequencies with percentages (qualitative variables) were measured. The Mann-Whitney U test for quantitative variables and the chi-square test for qualitative variables were used for comparison, with p <0.05 considered as significant.
Results:
The median age of the 78 participants was 65 years (IQR: 13.25 years). There were 63 (80.7%) males and 15 (19.3%) females. Thirty-five patients (44.8%) received MSC infusion, and 43 (55.2%) received placebo. The intervention group showed improvement in GFR at 6 months (median: 37.4; IQR: 21.7) compared to the placebo group (median: 26.4; IQR: 17.1; p = 0.013; 95% CI: -14.3 - -2.0). Post-treatment HbA1c levels were lower in the intervention group compared to the placebo group (median: 7.5; IQR: 1.4 vs. median: 8.4, IQR: 2.9, p = 0.002). The use of ACE inhibitors, ARBs, or SGLT2 inhibitors had no effects on GFR or HbA1c.
Conclusion:
MSC improved GFR and HbA1c at 6 months in patients with DKD (Stages II-IV).
Key Words:
Mesenchymal stem cells, Diabetic nephropathy, Glomerular filtration rate.
