30
Participants
Start Date
December 15, 2022
Primary Completion Date
November 1, 2025
Study Completion Date
November 1, 2025
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."
RECRUITING
Copenhagen Diabetes Foot Center (CODIF), Copenhagen
Lead Sponsor
Cell2Cure ApS
INDUSTRY