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Sponsored by: |
Harvest Technologies |
---|---|
Information provided by: | Harvest Technologies |
ClinicalTrials.gov Identifier: | NCT00595257 |
The purpose of this study is to determine if concentrated nucleated cells from your own bone marrow, injected or infused into an ischemic limb, will restore sufficient blood flow to avoid amputation.
Condition | Intervention | Phase |
---|---|---|
Arterial Occlusive Diseases |
Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Feasibility Study of the Safety and Activity of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Non Reconstructable Critical Limb Ischemia Due to Peripheral Arterial Occlusive Disease |
Estimated Enrollment: | 60 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
injection of BMAC into ischemic limb
|
Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
autologous bone marrow aspirate will be concentrated using the SmartPRep2 BMAC system and then injected/infused into ischemic limbs
|
2: Active Comparator
Injection and Infusion of BMAC into ischemic lower limb
|
Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
autologous bone marrow aspirate will be concentrated using the SmartPRep2 BMAC system and then injected/infused into ischemic limbs
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of Critical Limb Ischemia per protocol (see diagnostic criteria #2) with regard to the study limb.
Existence of a PAOD with clinical presentation corresponding to Rutherford Category 4 or Category 5 as defined in the reporting standards adopted by the Society of Vascular Surgeons (table 1)
Patient meets at least one of the following diagnostic criteria in the study limb:
There is no reasonable open surgical or endovascular revascularization option as determined by the treating vascular specialist. Factors that may contribute to the determination of inoperability may include:
Anatomical considerations
High risk medical conditions
The patient's unsuitability must be confirmed by 2 qualified physicians.
Exclusion Criteria:
Contact: K. S. Vijayraghavan, MS | 2476 8403/2476 8028 ext 599 | drksv@hotmail.com |
India, Chennai | |
Sri Ramachandra University Medical Center | Recruiting |
Porur, Chennai, India, 600 116 | |
Principal Investigator: K S Vijayaragavan, MS |
Study Director: | R E Arasan, MD | LifeCell India |
Responsible Party: | Harvest Technologies Corp ( Director of Quality & Regulatory Affairs ) |
Study ID Numbers: | TriCell/CT/IND-001 |
Study First Received: | December 19, 2007 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00595257 |
Health Authority: | India: Drugs Controller General of India |
PAD, CLI, Critical Limb Ischemia, bone marrow, stem cell, injection, infusion |
Arterial Occlusive Diseases Vascular Diseases Ischemia |
Cardiovascular Diseases |