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

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 15, 2022

Primary Completion Date

November 1, 2025

Study Completion Date

November 1, 2025

Conditions
Diabetic Foot UlcerMesenchymal 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."

Trial Locations (1)

Unknown

RECRUITING

Copenhagen Diabetes Foot Center (CODIF), Copenhagen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cell2Cure ApS

INDUSTRY