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Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot (FOOTCELL)

NCT06843122 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-02-24

No results posted yet for this study

Summary

The goal of this study is to investigate the safety and efficacy of allogenic mesenchymal stem cells isolated from adipose tissue as the treatment for chronic wounds in diabetic foot syndrome in a double-blinded three armed setup.

Conditions

  • Diabetic Foot Ulcer

Interventions

BIOLOGICAL

A - Allogenic ADSC cells in fibrin solution - two times administration ADSC/ASC

ADSC/ASC will be administered twice, at two-week intervals - during V0 and V2 visits The first dose will be administered one week after the randomisation visit. Control visits after administration will be performed every week, up to V6 visit (up to 6 weeks after V0).

BIOLOGICAL

B - Allogenic ADSC cells in fibrin solution - one time administration of ADSC/ASC, one time of placebo

ADSC/ASC will be administered once, at the time of the second application patients will receive a placebo - during V0 and V2 visits The first dose will be administered one week after the randomisation visit. Control visits after administration will be performed weekly, up to V6 visit (up to 6 weeks after V0)

OTHER

C - Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface.

Placebo will be administered twice, at two-week intervals - during V0 and V2 visits The first dose will be administered one week after the randomisation visit. Control visits after administration will be performed every week, up to V6 visit (up to 6 weeks after V0).

Sponsors & Collaborators

  • Medical Research Agency, Poland

    collaborator OTHER_GOV

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Beata Mrozikiewicz-Rakowska, Assoc.Prof. · Bielanski Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-08
Primary Completion
2027-02-28
Completion
2027-08-01

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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 NCT06843122 on ClinicalTrials.gov