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Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients.

NCT05595681 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-12-23

No results posted yet for this study

Summary

The STEMFOOT Pilot Study is a single center randomized open phase I clinical intervention pilot trial with the aim of investigating the treatment effect of an allogenic adipose-derived mesenchymal stromal cell product (C2C\_ASC) compared to conventional optimal treatment on healing and complications of foot ulcers in diabetes patients.

Conditions

  • Diabetic Foot Ulcer
  • Mesenchymal Stromal Cells

Interventions

DRUG

Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)

The investigational product is a C2C\_ASC cell product (Cell2Cure®, Cell2Cure ApS, Denmark). C2C\_ASC is an advanced therapy investigational medicinal product (ATIMP) manufactured from abdominal adipose tissue derived mesenchymal stromal cells (ASC) from healthy donors. C2C\_ASC is aseptically procured and manufactured according to tissue law and GMP by Cell2Cure ApS or Cardiology Stem Cell Center, Rigshospitalet, Copenhagen, Denmark, using manual isolation of cells from abdominal fat tissue, xeno-free cell expansion in automated closed bioreactor systems and cryopreservation of the final product. The active substance is the in vitro expanded ASCs. The final product, C2C\_ASC, is provided as a cryopreserved suspension of 50 million ASCs per ml with a total volume of 1,3 ml per vial. The exipient is CryoStor10 (Biolife Solutions), holding 10% DMSO.

Sponsors & Collaborators

  • Cell to Cure ApS

    lead INDUSTRY

Principal Investigators

  • Jens Kastrup · Cell to Cure ApS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2025-11-28
Completion
2025-11-28

Countries

  • Denmark

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 NCT05595681 on ClinicalTrials.gov