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

NCT06795620 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: RC31/21/01682023-509312-29-00
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Critical limb ischemia (CLI) is the most severe stage of peripheral arterial disease (PAD). Cell therapy delivered to the ischemic muscle constitutes a promising approach to treat CLI patients with no or poor options of vascularization. Pre-clinical study and clinical phase I have demonstrated the safety and feasibility of the use of autologous AdMSC treatment in patients without option for revascularization CLI patients and encouraging preliminary efficacy results have been highlighted in the pilot phase. In order to optimize AdMSC quality and to accelerate treatment availability researchers decide to test the use of allogeneic cryopreserved AdMSC from healthy donor. The aim of this phase I study is to evaluate the safety of allogeneic AdMSC injection in ischemic leg.

Conditions

Critical Limb Ischemia

Keywords

Adipose tissue; allogeneic AdMSC; cell therapy

Outcome Measures

Primary Outcomes (1)

• Evaluation of the tolerance

  local and systemic tolerance during 6 months by the collection and analysis of adverse events (serious or non-serious) throughout the duration of the study

  6 months

Secondary Outcomes (12)

• Evaluation of the efficacy of the treatment on critical limb ischemia.

  Day 30, Day 90, and Day 180

• Evaluation of the evolution of ischemia objective parameters.

  Day 0, Day 30, Day 90, and Day 180

• Evaluation of the healing.

  Day 30, Day 90, and Day 180

• Evaluation of the proportion of patients who required a major amputation.

  Day 180

• Evaluation of the pain Evolution

  Day 0, Day 7, Day 30, Day 90, and Day 180

Study Arms (1)

CellReady

EXPERIMENTAL

All the patients will be included and will have AdMSC injections (CellReady®) in their ischemic led. They will be follow-up during 6 months.

Drug: Adipose tissue derived mesenchymal Stroma/stem Cells transplantation

Interventions

Adipose tissue derived mesenchymal Stroma/stem Cells transplantation DRUG

Allogeneic adipose tissue-derived stromal cells (AdMSC) (CellReady ® drug) will be administered intramuscularly into the ischemic limb (dose of 90x10\^6 AdMSC) of patients. They will be followed at 1 day, 7 days, 30 days, 90 days, and 180 days after the injection.

CellReady

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France, France

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• François-Xavier LAPEBIE, Dr

  Service de Médecine Vasculaire, Hôpital Rangueil, CHU de Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François-Xavier LAPEBIE, Dr

CONTACT

+33 5 61 32 24 38; lapebie.fx@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 28, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)