Critical Limb Ischemia in patients with Diabetes Mellitus MedDRA version: 19.1 Level: LLT Classification code 10077142 Term: Limb ischemia System Organ Class: 100000004866 MedDRA version: 19.1 Level: LLT Classification code 10058069 Term: Critical limb ischemia System Organ Class: 100000004866 MedDRA version: 19.1
Conditions
Interventions
Product Name: Rexmyelocel-T
Product Code: N/A
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Concentrate of Autologous adult non-expand
Sponsors
Rexgenero Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for this trial subjects must satisfy all of the following criteria: 1. Aged = 18 to = 85 years. 2. Diagnosis of Type I or II DM, established more than one year ago. 3. Glycosylated hemoglobin (HbA1c) =65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the trial: 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 any ulceration that extends beyond the subcutaneous tissue layer, or any gangrene or tissue necrosis proximal to the metatarsal heads. 2. CLI Rutherford Category 4. 3. Uncontrolled or untreated proliferative retinopathy. 4. Failed surgical or endovascular revascularization on the index leg within 10 days after the procedure. 5. 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). 6. Clinical evidence of invasive infection on index leg defined as major tissue loss at the mid-foot or heel involving tendon and/or bone, and/or when intravenous antibiotics are required to treat the infection according to the Investigator. 7. At screening, the presence of only neuropathic ulcers on the index leg. 8. Amputation at or above the talus on the index leg. 9. Planned major amputation within the first month after randomization. 10. On the index leg, use of concomitant wound treatments not currently approved for ischemic wound-healing within 30 days prior to screening or plans to initiate new, nonstandard-of-care treatments to the index leg during the trial. 11. Blood clotting disorder not caused by medication (e.g., thrombophilia). 12. Severe hypertension according to the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. (34) 13. A platelet count 1.5. 15. Evidence of moderate to severe hepatocellular dysfunction according to the treating physician. 16. Positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus (HBV), hepatitis C virus (HCV) or Treponema pallidum. 17. 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. For example: a. Concurrent severe congestive heart failure (New York Heart Association Classes III and IV). b. Life-threatening ventricular arrhythmias, unstable angina (characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration), and/or myocardial infarction within four weeks before screening. c. Coronary artery bypass grafting or percutaneous coronary intervention within one month before screening. d. A renal and/or carotid revascularization procedure within one month of screening. e. Transient ischemic attack within three months prior to screening. f. Deep vein thrombosis within three months prior to screening. g. Subjects with immunocompromised con
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective Trial 2 The objective of this trial is to confirm the efficacy and safety of an intra-arterial administration of Rexmyelocel-T to treat ischemic ulcers in subjects with DM and CLI Rutherford Category 5. ;Secondary Objective: Not applicable; Primary end point(s): Primary Efficacy Endpoint Trial 2 Change in Rutherford classification from CLI Category 5 to Category 4 or lower 12 months after administration of Rexmyelocel-T or placebo. Success is defined as complete healing of all ischemic ulcers on the index leg. ;Timepoint(s) of evaluation of this end point: 12 months after administration of Rexmyelocel-T or placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following secondary endpoints at 12 months after administration of Rexmyelocel-T or placebo are defined: • Change in Rutherford classification from CLI Category 5 to Category 3 or lower. • Partial healing of ischemic ulcers (> = 50% reduction in size as compared to ulcer size at baseline). • AFS. ;Timepoint(s) of evaluation of this end point: 12 months after administration of Rexmyelocel-T or placebo | — |
Countries
Austria, Czech Republic, Hungary, Netherlands, Poland, Portugal, Spain, United Kingdom
Contacts
Public ContactChief Operating Officer
Rexgenero Limited
Outcome results
None listed