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

Sponsor
Medical University of Warsaw
Study ID
NCT06843122
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • A - Allogenic ADSC cells in fibrin solution - two times administration ADSC/ASC — BIOLOGICAL
    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).
  • B - Allogenic ADSC cells in fibrin solution - one time administration of ADSC/ASC, one time of placebo — BIOLOGICAL
    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)
  • C - Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface. — OTHER
    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).

Study Details

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.

Key Dates

First listed
Feb 24, 2025
Start date
Mar 8, 2025
Status verified
Nov 2024
Primary completion
Feb 28, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: A - ADSC/ASC cells in fibrin solution - two times administration of ADSC/ASC
    Application of allogeneic ADSC stem cells in fibrin gel, to cover wound surface with thin cells layer. Therapy is based on standard of care procedure for diabetic foot ulcer treatment combined with application of allogeneic ADSC stem cells in fibrin solution onto the wound surface.
  • Experimental: B - ADSC/ASC cells in fibrin solution - one administration of ADSC/ASC, one administration placebo
    Application of allogeneic ADSC stem cells and placebo in fibrin gel, to cover wound surface with thin cells layer. Therapy is based on standard of care procedure for diabetic foot ulcer treatment combined with application of allogeneic ADSC stem cells and placebo in fibrin solution onto the wound surface.
  • Placebo Comparator: C - Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface.
    Standard of care procedure for diabetic foot ulcer with aplication of fibrin gel to cover wound surface. Application of fibrin gel to cover wound surface.

Primary Outcome Measure

Change in wound size (%) at 6 weeks after first study treatment administration compared to baseline with the actual wound size measured by the independent assessor. [ Time Frame: 6 weeks after the first administration ]

Central Contacts

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