A clinical trial to test the efficacy and safety of a bone marrow cell preparation to treat Critical Limb Ischemia in Subjects with Diabetes Mellitus.

Phase 1

• Conditions: 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 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-000240-34-ES
• Lead Sponsor: Rexgenero Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 141

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 < 70 mm Hg, or toe systolic pressure < 50 mm Hg or TcPO2 < 30 mm Hg.
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 71

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.

Study & Design

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