The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM

Phase 3

Terminated

• Conditions: Peripheral Arterial Disease (PAD); Diabetes Mellitus (DM); Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Cardiovascular Disease; Critical Limb Ischemia (CLI)
• Interventions: Drug: REX-001; Drug: Placebo

• Registration Number: NCT03174522
• Lead Sponsor: Ixaka Ltd

Brief Summary

This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5. Minimisation will be used to assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of REX-001 or matching placebo into the index limb.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-25
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-02
• Primary Completion: 2023-02-13
• Study Completion: 2023-02-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REX-001	REX-001	REX-001 is a cell suspension of autologous bone marrow mononuclear cells (BM-MNCs) composed of several mature cell types.
Placebo	Placebo	The final formulation of the placebo will be a diluted suspension of red blood cells.

Primary Outcome Measures

Name	Time	Method
Complete healing of all ischemic ulcers on the index leg.	The primary endpoint for this trial will be assessed at 12 months.	Change in Rutherford classification from CLI Category 5 to Category 4 or lower 12 months. after administration of REX-001 or placebo.

Trial Locations

Locations (15)

Hospital Regional Universitario; 🇪🇸 Málaga, Spain

Centro Hospitalar de São João; 🇵🇹 Porto, Portugal

Hospital Universitario Puerta del Mar; 🇪🇸 Cadiz, Spain

Hospital General Universitario Morales Meseguer; 🇪🇸 Murcia, Spain

Centro Hospitalar Lisboa Norte, EPE; 🇵🇹 Lisboa, Portugal

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom

Pécsi Tudományegyetem, PTE-KK I. sz Belgyógyászati Klinika; 🇭🇺 Pécs, Hungary

Maastricht Universitair Medisch Centrum; 🇳🇱 Maastricht, Netherlands

Fakultní nemocnice Ostrava; 🇨🇿 Ostrava, Czechia

Leids Universitair Medisch Centrum; 🇳🇱 Leiden, Netherlands

Hospital Garcia de Orta, EPE; 🇵🇹 Almada, Portugal

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet De Llobregat, Barcelona, Spain

First site: Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain