NCT03111238

The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM

Terminated Phase 3 Last updated 7 May 2021

What this trial tests

Phase 3 trial testing REX-001 in Peripheral Arterial Disease (PAD) in 3 participants. Terminated before completion.

Timeline

5 April 2017

Primary endpoint
31 March 2021

31 March 2021

Quick facts

Lead sponsor	Ixaka Ltd
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	3
Start date	5 April 2017
Primary completion	31 March 2021
Estimated completion	31 March 2021
Sites	15 locations across Germany, Poland, Hungary, Portugal, Spain, Czechia

Drugs / interventions tested

• REX-001 — full drug profile →
• Placebo

Conditions studied

• Peripheral Arterial Disease (PAD) — all drugs for Peripheral Arterial Disease (PAD) →
• Diabetes Mellitus (DM) — all drugs for Diabetes Mellitus (DM) →
• Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Ixaka Ltd — full company profile →

Who can join

Adults 18 to 85, any sex, with Peripheral Arterial Disease (PAD) or Diabetes Mellitus (DM). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 4. 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cell therapies in the clinic.
   Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214
2. Current Status of Angiogenic Cell Therapy and Related Strategies Applied in Critical Limb Ischemia.
   Beltrán-Camacho L, Rojas-Torres M, Durán-Ruiz MC. · · 2021 · cited 48× · PMID 33652743 · DOI 10.3390/ijms22052335
3. Therapeutic angiogenesis-based strategy for peripheral artery disease.
   Han J, Luo L, Marcelina O, Kasim V, et al · · 2022 · cited 46× · PMID 35836800 · DOI 10.7150/thno.74785
4. REX-001, a BM-MNC Enriched Solution, Induces Revascularization of Ischemic Tissues in a Murine Model of Chronic Limb-Threatening Ischemia.
   Rojas-Torres M, Jiménez-Palomares M, Martín-Ramírez J, Beltrán-Camacho L, et al · · 2020 · cited 6× · PMID 33363160 · DOI 10.3389/fcell.2020.602837