Safety and Efficacy Study of Autologous BM-MNC Processed by Two Methods for Treating Patients With Chronic Limb Ischemia
NCT ID: NCT01446055
Last Updated: 2011-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2011-10-31
2013-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ResQ process group
Autologous BM-MNC is enriched with ResQ process(an automatic cell separator). Then the cell product is transplanted into the ischemia limbs of a patient.
ResQ processed bone marrow sample
Autologous bone marrow is processed with ResQ at point of care, prior to the transplantation
Ficoll-based conventional method
A conventional method based on Ficoll cell separation is used to process bone marrow.
Ficoll conventional cell processing method
Comparison of different cell processing methods
Interventions
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ResQ processed bone marrow sample
Autologous bone marrow is processed with ResQ at point of care, prior to the transplantation
Ficoll conventional cell processing method
Comparison of different cell processing methods
Eligibility Criteria
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Inclusion Criteria
2. age between 20 and 80 years old
3. sign informed consent, voluntary subjects
4. diagnosis of lower extremity arterial occlusive disease, or diabetic lower limb ischemia, or Buerger's disease
Exclusion Criteria
2. malignancy history in the past five years or serum level of tumor markers elevated more than doubled
3. severe heart, liver, kidney, respiratory failure or poor general condition can not tolerate BM-MNC transplantation
4. serious infections (such as cellulitis, osteomyelitis, etc.)or gangrene that a major amputation cannot be avoided
5. aortic or iliac or common femoral artery occlusion
6. pregnant female, or reproductive age female who wants to give birth throughout the course of the study
7. life expectancy less than a year
20 Years
80 Years
ALL
No
Sponsors
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Thermogenesis Corp.
INDUSTRY
Hebei Medical University
OTHER
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Yong-Quan Gu
Director of Vascular Surgery Department, Principal Investigator, Clinical Professor
Principal Investigators
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Yong-Quan Gu, Dr.
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Beijing
Locations
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Xuan Wu Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TGResQ082011
Identifier Type: -
Identifier Source: org_study_id