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

NCT07039318 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-06-26

No results posted yet for this study

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

Interventions

BIOLOGICAL

Mesenchymal stem cells

Mesenchymal stem cells

DRUG

Normal Saline (Placebo)

Normal Saline (Placebo)

Sponsors & Collaborators

  • Pak Emirates Military Hospital

    collaborator OTHER

  • National Institute of Blood and Marrow Transplant (NIBMT), Pakistan

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2025-02-28
Completion
2025-05-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07039318 on ClinicalTrials.gov