Critical Limb Ischemia in patients with Diabetes Mellitus MedDRA version: 19.0 Level: LLT Classification code 10077142 Term: Limb ischemia System Organ Class: 100000004866 MedDRA version: 19.0 Level: LLT Classification code 10058069 Term: Critical limb ischemia System Organ Class: 100000004866 MedDRA version: 19.0
Conditions
Interventions
Product Name: Rexmyelocel-T
Product Code: not applicable
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Autologous adult non-expanded b
Sponsors
Rexgenero Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged ? 18 to ? 80 years. 2. Diagnosis of Type I or II DM, established more than one year ago. 3. Subjects with poor or no revascularization option (i.e., surgical or endovascular revascularization), in general classified as CLI Rutherford Category 4 or 5, including ankle systolic pressure =65 years) yes F.1.3.1 Number of subjects for this age range 71
Exclusion criteria
Exclusion criteria: 1. Advanced CLI defined as presence of major tissue loss as significant ulceration/gangrene proximal to the metatarsal heads (CLI Rutherford Category 6). Significant ulceration/gangrene means anyulceration that extends beyond the subcutaneous tissue layer, or any gangrene or tissue necrosis proximal to the metatarsal heads. 2. Uncontrolled or untreated proliferative retinopathy. 3. Failed surgical or endovascular revascularization on the index leg within 10 days of the Screening Visit (Visit A). 4. Subjects in whom arterial insufficiency in the lower extremity is the result of acute limb ischemia or an immunological or inflammatory or non-atherosclerotic disorder (e.g., thromboangiitis obliterans (Buerger?s Disease), systemic sclerosis (both limited and diffuse forms). 5. Clinical evidence of invasive infection on index leg (foot sepsis). 6. At screening, the presence of one or more neuropathic ulcers on the index leg and no ischemic ulcers. 7. Amputation at or above the talus on the index leg. 8. Planned major amputation within the first month after randomization. 9. Subjects who may not be healthy enough to successfully complete all protocol requirements including BM collection, or who are not expected to survive more than 12 months, or in whom results may be particularly difficult to assess, as assessed by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy and safety of a single intra-arterial administration of Rexmyelocel-T to treat critical limb ischemia (CLI) in subjects with diabetes mellitus (DM) by restoring blood flow, treating ulcers, improving mobility, and improving the quality of life (QOL).;Secondary Objective: Not applicable; Primary end point(s): Clinically relevant response in the Rutherford Category at 12 months after administration of Rexmyelocel-T or placebo. Clinical response is defined as change in Rutherford classification from CLI Category 4 or 5 to Category 3 or lower at 12 months after administration. ; Timepoint(s) of evaluation of this end point: 12 months post-administration of Rexmyelocel-T or placebo. A blinded independent adjudication committee (IAC) will confirm the eligibility of all subjects before a subject is randomized, and interpret clinical and hemodynamic data to confirm the Rutherford Category of PAD of each subject at the Baseline Visit (Visit 1) and at 3, 6, 12, 18 and 24 months after administration of Rexmyelocel-T or placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in Rutherford score (Categories 0-6). ? Presence of ischemic ulcers (yes/no). ? Presence of ischemic rest pain (yes/no). ? Amputation free survival (AFS). ;Timepoint(s) of evaluation of this end point: 12 months post administration of Rexmyelocel-T or placebo | — |
Countries
Austria, Hungary, Netherlands, Poland, Portugal, Spain
Contacts
Public ContactChief Operating Officer
Rexgenero Limited
Outcome results
None listed