Tolerance Study of Allogeneic of Adipose Tissue Derived Mesenchymal Stroma/Stem Cells (AdMSC) Transplantation in Patients With Critical Limb Ischemia.

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with Critical Limb Ischemia (CLI), a serious condition where blood flow to the legs is severely restricted, causing pain and potential tissue damage. Researchers want to see if injecting cryopreserved stem cells from healthy donors can help improve blood flow and healing in patients who have no options for traditional surgeries. This study is in its early phase, focusing on ensuring that this new treatment is safe for patients.

To be eligible for the trial, participants must be adults over 18 years old with a confirmed diagnosis of CLI, meaning they experience severe pain or other symptoms due to poor blood circulation. They should not be candidates for surgery to improve blood flow, and they must have a life expectancy of at least six months. Participants will need to provide informed consent and be willing to follow certain guidelines, including using effective contraception if they are women of childbearing age. This trial is not yet recruiting, but it represents an important step toward finding new ways to help those suffering from CLI.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients over 18 years old,
• • Patients with CLI according international definition: 1) rest pain of ischemic origin or ischemic trophic disorder present for at least 15 days, and 2) an ankle pressure ≤50 mmHg (≤70 mmHg for diabetic patients) or a toe pressure ≤30 mmHg or a TcPO2 ≤30 mmHg,
• • Patient not revascularizable by decision of the surgeon or anesthesiologist orpatient with persistent critical ischemia after revascularization,
• • Patient with a life expectancy greater than 6 months,
• • Patients who signed the informed consent,
• • Women of childbearing age with effective contraception (oral contraception, IUD, dermal implant) and with negative pregnancy test,
• • Patient affiliated to a social security system.
• Exclusion Criteria:
• • Need of a major amputation (amputation at or above the ankle) within 1 month following the inclusion,
• • Another clinical trial participation (except observational studies),
• • Patient with active cancer history in the 5 previous years except cured basal cell carcinoma or cured low-stage melanoma,
• • Patient allergic to local anesthetics
• • Immunosuppressive therapy
• • Ulcers with exposure of tendons, osteomyelitis, or clinically uncontrolled infection,
• • Patient under the protection of justice or under guardianship or curatorship.