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).
Conditions
Interventions
Product Name: Suspension of allogeneic MSC from umbilical cord for treatment of Critical Limb Ischemia
Product Code: HBMSC1
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the pla
Sponsors
Centre Hospitalier Universitaire de Reims
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: Preliminary evaluation of efficacy and dose effect relationship of the MSC implantation in hemodynamic, anatomical and functional terms.;Primary end point(s): Criteria for safety: Tolerance will be evaluated over the study follow-up: - Local tolerance: inflammation, pain, or any other unexpected symptom, - Systemic tolerance: pulse, arterial pressure, fever or any other abnormal symptom, - Biological tolerance, - Adverse events (AEs) and serious adverse events (SAEs), - Vital signs. The primary safety endpoint will be the occurrence of any high grade AEs (grade 2 and more), either serious or not, assessed as related to the cell implantation by the investigator, reported over the 360 days of the study period. ;Timepoint(s) of evaluation of this end point: At 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At 12 months;Secondary end point(s): Assessment of preliminary efficacy is a secondary objective of the study. Primary efficacy endpoint: transcutaneous oxygen pressure (TcPO2) Secondary efficacy endpoints: - Hemodynamic endpoints: toe pressure, ankle pressure, ankle brachial index (ABI), - Functional endpoints: pain at rest, trophic disorders, ulcers, - Anatomical endpoints: Doppler ultrasound assessing permeability, thrombosis and restenosis of revascularization, - Clinical events: target limb re-intervention, minor or major target limb amputation, death of any cause. | — |
Countries
France
Contacts
Public ContactPr Ambroise DUPREY
Centre Hospitalier Universitaire de Reims
Outcome results
None listed