Mesenchymal Stem Cell Therapy in Diabetic Kidney Disease-A Double-blind, Placebo-controlled, Randomized Clinical Trial

NCT07039318 | Completed Phase 2

• 1 other identifier: MSC-CKD/2022
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

Diabetes had global prevalence of 9% in 2014 and is increasing alarmingly, affecting approximately 387 million people worldwide. It is strongly linked to complications, like chronic kidney failure, blindness and neurdegeneration. From 1999-2006, prevalence of chronic kidney disease (CKD) stage 1-2 was 11.5%, and stage 3-4 was 58%, while its prevalence in Pakistan is 12.5%. CKD is a pathophysiological process with multiple etiologies, eventually resulting in irreversible nephron damage and leading to End Stage Renal Disease (ESRD), rendering the patient permanently dependent on Renal Replacement. In Pakistan, the prevalence of diabetic ESRD is 22%. Only supportive management is offered, resulting in either dialysis dependency or transplant. High CKD prevalence, renal replacement therapy and associated morbidity-mortality demands more effective and easier treatment option. We propose Mesenchymal Stem Cells (MSC) therapy for reversing the chronic kidney damage caused by type2 diabetes.

Conditions

Diabetic Kidney Disease

Keywords

diabetic kidney disease; mesenchymal stem cells; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• isotopic DTPA Scan

  Glomerular Filtration Rate using Renal isotope 99mTc-DTPA

  To be carried out at enrollment and at six months' post-intervention

Secondary Outcomes (1)

• Glycosylated Hemoglobin level

  To be carried out at baseline and at six months post-intervention

Study Arms (2)

Mesenchymal stem cells

EXPERIMENTAL

Mesenchymal stem cells (30 million cells)

Biological: Mesenchymal stem cells

Normal Saline (Placebo)

PLACEBO COMPARATOR

Normal Saline (Placebo)

Drug: Normal Saline (Placebo)

Interventions

Mesenchymal stem cells BIOLOGICAL

Mesenchymal stem cells

Mesenchymal stem cells

Normal Saline (Placebo) DRUG

Normal Saline (Placebo)

Normal Saline (Placebo)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients between 18 and 75 years of age having Type-2 Diabetes with CKD stage 2,3 and 4: (eGFR 15-90 mL/min/1.73 m2).

You may not qualify if:

• Patients with a history of other comorbidities like previous myocardial infarction, pulmonary disease, pregnant females, unable to follow or return for evaluation.

Sponsors & Collaborators

• National Institute of Blood and Marrow Transplant (NIBMT), Pakistan: lead
• Pak Emirates Military Hospital: collaborator

Study Sites (2)

National Institute of Blood and Marrow Transplant (NIBMT), Pakistan/Armed Forces Bone Marrow Transplant Centre

Rawalpindi, 46000, Pakistan

Location

Pak Emirates Military Hospital, Rawalpindi (PEMH)

Rawalpindi, 46000, Pakistan

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is an interventional, double blind, randomized, controlled clinical trial where participants either receive mesenchymal stem cells (30 million cells) or placebo.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: December 1, 2022
• Primary Completion: February 28, 2025
• Study Completion: May 31, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

PA (2)