Cell therapy in Critical Limb Ischemia by implantation of allogeneic umbilical cord-derived mesenchymal stem cells

Phase 1

• Conditions: Evaluation of the feasibility and systemic and local tolerance of an implantation, via intramuscular route, of allogenic HB-MSC1, associated with a revascularization procedure, in patients suffering from critical limb ischemia (CLI).; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-004563-31-FR
• Lead Sponsor: Centre Hospitalier Universitaire de Reims

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-15
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. The patient is suffering from critical limb ischemia and is being subject to a revascularization procedure, associated or not to minimally invasive surgery,
2. The patient (or his/her legal representative(s)) is capable to understand and comply with study requirements and to provide written informed consent prior to any study procedure for participation in the study and transmission of personal anonymized data, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form (ICF).
3. Male or female patients aged =18 years at the time of signing the ICF.
4. A female patient is eligible to participate if she is of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) will be required to use one of the treatment methods that does not modify hemostasis parameters (eg chlormadinone acetate [Lutéran]) or must discontinue HRT to allow confirmation of post-menopausal status prior to being enrolled in the study.
5. Diabetic patients with an eye fundus examination of less than 3 months excluding proliferative retinopathy
6. Patient with a life expectancy >12 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1.Patients presenting a failure of the revascularization procedure
2.The patient has, or has a history of, any significant disease or disorder that would increase the risk for the patient if they were enrolled in the study or would affect study procedures or outcomes.
3.The patient is mentally or legally incapacitated.
4.Patient protected by law.
5.Patient who does not benefit from the national health insurance coverage.
6.The patient has been involved in a previous trial with the investigational product.
7.History of cancer excepting basocellular epithelioma during the past 5 years.
8.Patient necessitating chronic hemodialysis or creatinine clearance inferior to 30 mL/min.
9.History of stroke or myocardial infarction of less than 3 months.
10.Hemostasis disorder with contra-indication of intramuscular injections.
11.Patients receiving dual antiplatelet therapy that cannot be temporarily discontinued at least 4 days before and until 6 hours after cell implantation.
12.Patient receiving an antiplatelet therapy with an adenosine diphosphate receptor inhibitor (ADP/P2Y12 inhibitor) that cannot be temporarily discontinued at least 4 days before and until 6 hours after cell implantation.
13. Patient receiving an anticoagulant treatment that cannot be temporarily discontinued until 2 days after the study treatment injection.
14.Patients subject to a below the knee femoro-popliteal bypass procedure or to a femoro-tibial bypass procedure
15.Patients included in another therapeutic trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified