A clinical trial to test the efficacy and safety of intra-arterial administration of REX-001 to treat ischaemic ulcers in subjects with Critical Limb Ischaemia Rutherford Category 5 and Diabetes Mellitus.

Phase 1

• Conditions: Critical Limb Ischemia in patients with Diabetes Mellitus; MedDRA version: 21.1Level: LLTClassification code 10077142Term: Limb ischemiaSystem Organ Class: 100000004866; MedDRA version: 24.0Level: LLTClassification code 10058069Term: Critical limb ischemiaSystem Organ Class: 100000004866; MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003980-21-PT
• Lead Sponsor: Rexgenero Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-07
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Trial Population
Main inclusion Criteria
1. Aged = 18 to = 85 years.
2. Diagnosis of Type I or II DM, established more than one year ago.
3. Subjects with poor or no (surgical or endovascular) revascularization option classified as CLI Rutherford Category 5.
The blood circulation in these subjects must be compromised at screening, defined as:
• Ankle systolic pressure < 70 mmHg, or
• Toe systolic pressure < 50 mmHg, or
• Transcutaneous oxygen pressure (tcpO2) < 30 mmHg (lying down).
Subjects with non-compressible vessels must qualify on toe pressure or tcpO2.
Poor or no revascularization option means that, in the opinion of the Investigator, revascularization using surgical or endovascular methods is not feasible due to unsuitable anatomy of existing vessels, existing comorbidity and/or previously failed surgical or endovascular revascularization.
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 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

Main Exclusion Criteria
1. Advanced CLI defined as presence of major tissue loss (i.e, significant ulceration and/or 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 prior to screening.
5. Subjects in whom arterial insufficiency in the lower extremity is the result of acute limb ischaemia or an immunological or inflammatory or non-atherosclerotic disorder (e.g., thromboangiitis obliterans (Buerger's Disease), or 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 according to the Investigator intravenous antibiotics are required to treat the infection.
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. 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