Peripheral Arterial Disease Clinical Trial
Official title:
Transplantation of Autologous BM-MNC Processed by ResQ Separator and Conventional Manual Method for Patients With Chronic Limb Ischemia: a Multi-center Randomized Controlled Trial
Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb ischemia has been proved safe and effective. However, processing bone marrow by Ficoll density gradient centrifugation is not only time consuming but also expensive. Manually processing of bone marrow also results in large variation in therapeutic cell quantity and quality which directly leads deviation of safety and efficacy of the cell therapy. This study is aiming to compare an automated bone marrow processing system with a conventional manual method in term of safety and efficacy.
Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb
ischemia has been proved safe and effective. However, processing bone marrow by Ficoll
density gradient centrifugation is not only time consuming but also expensive. Manually
processing of bone marrow also results in large variation in therapeutic cell quantity and
quality which directly lead deviation of safety and efficacy of the cell therapy. This study
is aiming to compare an automated bone marrow processing system with a conventional manual
method in term of safety and efficacy.
ResQ system developed by Thermogenesis in USA provides an automatic cell processing system
for bone marrow. The system takes less than 30 minutes to concentrate the therapeutic
mononuclear cells including stem cells in a closed system without adding any additive such
as separation reagent (Ficoll). The system also be able to be operated at point of care.
The study is designed to prove no inferior of safety and efficacy of bone marrow cells
processed by ResQ to those of cells using conventional manual method. The conventional
manual method is involved Ficoll density gradient centrifugation and cell washing stems in
an open system. Each of test arms (ResQ vs manual method) consists of 25 patients. The
primary outcome is safety which is measured by cell treatment-related adverse events. The
secondary endpoints include resting ankle-brachial pressure index (ABI)and toe brachial
pressure index (TBI) , transcutaneous oxygen pressure (TcPO2), claudication distance, rest
pain scale evaluation, collateral vessel scale, etc.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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