FindTrial
Sign In

The Efficacy and Safety of Intra-Arterial Administration of REX-001 to treat ischaemic rest pain in Subjects with Critical Limb Ischaemia Rutherford Category 4 and Diabetes Mellitus: A Pivotal, Placebo Controlled, Double-Blind, Parallel-Group, Adaptive Trial

The Efficacy and Safety of Intra-Arterial Administration of REX-001 to treat ischaemic rest pain in Subjects with Critical Limb Ischaemia Rutherford Category 4 and Diabetes Mellitus: A Pivotal, Placebo Controlled, Double-Blind, Parallel-Group, Adaptive Trial - REX-001-004 Rutherford Category 4

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47803
Enrollment
6
Registered
2017-01-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peripheral artery disease

Interventions

REX-001 is an autologous cell suspension for infusion, administered through an intra-arterial catheter. The subject will receive one batch of REX-001 at a target dose of 1 × 109 WBCs (range: 5 × 108

Sponsors

Rexgenero Limited
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 to

Exclusion criteria

Exclusion criteria: 1. Advanced CLI defined as presence of major tissue loss (i.e.as 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 5. 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.

Design outcomes

Primary

MeasureTime frame
Primary Efficacy Endpoint: Change in Rutherford classification from CLI Category 4 to Category 3 or lower 12 months after administration of REX-001 or placebo. Success is defined as complete relief of ischaemic rest pain with the absence of the development of ischaemic lesions on the index leg.—

Secondary

MeasureTime frame
The following secondary endpoints at 12 months after administration of REX-001 or placebo are defined: • Change in Rutherford score (Categories 0-6). • Presence of ischaemic ulcers (yes/no). • Amputation free survival (AFS).—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)