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Safety and Efficacy of Stem Cells for Diabetic Foot Ulcer

NCT06231771 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-03-06

No results posted yet for this study

Summary

The objective of this clinical trial is to evaluate the effectiveness and safety of Wharton-Jelly mesenchymal stem cells administered around the ulcer site in patients with nonhealing diabetic foot ulcers. The key inquiries it seeks to address include the percentage of patients achieving complete healing/closure of the specified ulcer at any point during the 6-week period, the duration required for the complete closure of the target ulcer, and the nature and occurrence of adverse events (AEs), along with the total number of AEs and the proportion of patients experiencing AEs.

Patients meeting the eligibility criteria will receive either allogeneic mesenchymal stromal cells (MSC) or a placebo. The peri-ulcer injection of umbilical cord MSC or placebo will be administered at multiple locations, around the ulcer. Subsequent follow-up after the administration of umbilical cord MSC or placebo will be conducted to monitor and observe the progress of ulcer healing.

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

Allogeneic mesenchymal stem cells (MSCs)

Dosage · Dosing of IMP is based on ulcer size. The recommended dose is 1 million cells/cm2 of ulcer. Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients)

DRUG

Normal Saline

Dosage · Dosing of placebo is based on ulcer size. the volume will be samed as the experimental groups which is 2 ml per 1cm2 Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients)

Sponsors & Collaborators

  • Supergenics Life Science Sdn. Bhd.

    lead INDUSTRY

Principal Investigators

  • Mohd Yazid Bajuri · Hospital Canselor Tunku Muhriz (HCTM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2024-10-31
Completion
2024-12-30

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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 NCT06231771 on ClinicalTrials.gov