Critical Limb Ischemia Rutherford clas 4-6
Conditions
Interventions
Product Name: ASCT01
Product Code: ASCT01
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intraarterial
Sponsors
XCell-Center GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients in the age group of 18-75 yrs. 2. Established CLI (confirmed by Rutherford 4 to 6 or Fontaine III-IV to the recommendations of the TASC) with infra-inguinal arterial occlusive disease 3. Ankle Brachial Pressure Index (ABPI) = 0.6 or the absolute ankle blood pressure 2 million CD34+). 9. Viability of isolated stem cells > 90%. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Acute life threatening complication of limb ischemia with the need for immediate limb amputation to avoid death or clinical deterioration 2. Patients with documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 6 months. 3. Patients with a history of severe alcohol or drug abuse within 3 months of screening. 4. Known bone marrow diseases which preclude transplantation. 5. End-stage renal failure on regular dialysis treatment 6. Patients already enrolled in another investigational drug trial or completed within 3 months. 7. Pregnancy. 8. Patients tested positive for HIV 1, HCV, and/or HBV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to compare the effects of treatment with ASCT01 in patients with an endstage Critical Limb Ischemia vs a placebo therapy.;Secondary Objective: To assess the safety profile of ASCT01 during the study To document other efficacy parameters such as: a.major Amputations and wound healing Changes in: b. Ankle-Brachial Index (AB-index) c. Transcutaneous oxygen pressure (Tcp02) d. Quality of life (EQ-5D Questionnaire) e. Rutherford grade and stage f. Angiography g. Walking index in speed and distance without and with pain h. Wound healing;Primary end point(s): The primary outcome variable is a major amputation (above the ankle) of the affected limb after 3 months or an unchanged critical limb ischemia of the affected limb after 3 months defined as less than 15% change in tcPO2 or ABI or absolute ankle pressure. | — |
Countries
Czech Republic
Outcome results
None listed