Safety and Efficacy Study of Autologous BM-MNC Processed by Two Methods for Treating Patients Wit… (NCT01446055) | Clinical Trial Compass
UnknownPhase 1/2
Safety and Efficacy Study of Autologous BM-MNC Processed by Two Methods for Treating Patients With Chronic Limb Ischemia
China50 participantsStarted 2011-10
Plain-language summary
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.
Who can participate
Age range20 Years – 80 Years
SexALL
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Inclusion criteria
✓. fontaine's stage 2-4 or resting ABI \<0.7
✓. age between 20 and 80 years old
✓. sign informed consent, voluntary subjects
✓. diagnosis of lower extremity arterial occlusive disease, or diabetic lower limb ischemia, or Buerger's disease