NCT03339973

Allogeneic ABCB5-positive Stem Cells for Treatment of PAOD

Terminated Phase 1, PHASE2 Last updated 29 June 2020

What this trial tests

Phase 1, PHASE2 trial testing allo-APZ2-PAOD in Peripheral Arterial Occlusive Disease in 24 participants. Terminated before completion.

Timeline

5 March 2018

Primary endpoint
15 May 2020

15 May 2020

Quick facts

Lead sponsor	RHEACELL GmbH & Co. KG
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	5 March 2018
Primary completion	15 May 2020
Estimated completion	15 May 2020
Sites	18 locations across Austria, United Kingdom, Germany, Poland, Czechia

Drugs / interventions tested

• allo-APZ2-PAOD — full drug profile →
• Placebo

Conditions studied

• Peripheral Arterial Occlusive Disease — all drugs for Peripheral Arterial Occlusive Disease →

Sponsor

RHEACELL GmbH & Co. KG — full company profile →

Who can join

Adults 45 to 85, any sex, with Peripheral Arterial Occlusive Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of Peripheral Arterial Occlusive Disease-related clinically relevant ulcers) and safety (by monitoring adverse events) of one dose of allo-APZ2-PAOD administered intramuscularly into an affected lower leg of patients with Peripheral Arterial Occlusive Disease.

Publications & conference data

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

1. The Role of Mesenchymal Stem Cells in Atherosclerosis: Prospects for Therapy via the Modulation of Inflammatory Milieu.
   Mahdavi Gorabi A, Banach M, Reiner Ž, Pirro M, et al · · 2019 · cited 29× · PMID 31500373 · DOI 10.3390/jcm8091413
2. Autologous cells derived from different sources and administered using different regimens for 'no-option' critical lower limb ischaemia patients.
   Abdul Wahid SF, Ismail NA, Wan Jamaludin WF, Muhamad NA, et al · · 2018 · cited 29× · PMID 30155883 · DOI 10.1002/14651858.cd010747.pub2
3. Locoregional delivery of stem cell-based therapies.
   Ng NN, Thakor AS. · · 2020 · cited 24× · PMID 32522806 · DOI 10.1126/scitranslmed.aba4564
4. Process data of allogeneic ex vivo-expanded ABCB5⁺ mesenchymal stromal cells for human use: off-the-shelf GMP-manufactured donor-independent ATMP.
   Ballikaya S, Sadeghi S, Niebergall-Roth E, Nimtz L, et al · · 2020 · cited 21× · PMID 33198791 · DOI 10.1186/s13287-020-01987-y
5. Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia.
   Moazzami B, Mohammadpour Z, Zabala ZE, Farokhi E, et al · · 2022 · cited 4× · PMID 35802393 · DOI 10.1002/14651858.cd008347.pub4