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Sponsored by: |
TheraVitae Ltd. |
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Information provided by: | TheraVitae Ltd. |
ClinicalTrials.gov Identifier: | NCT00523731 |
Study title: A Study of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients with Critical Limb Ischemia ( ACPs-CLI )
Principle Investigator: Assoc.Prof. Pramook Mutirangura,M.D. Head of Division of Vascular Surgery , Department of Surgery, Faculty of Medicine Siriraj Hospital , Mahidol University, BKK,Thailand
Study objective : To determine the safety and efficacy of intramuscular injection of blood-borne autologous ACPs in relieving symptoms of critical limb ischemia of patients treated with maximal medical therapy and don't have intravascular or operative revascularization option.
Study Design : A pilot study , a single center, a non-randomized, open-label trial.
Total expected no. of patients : 6 main selection criteria : A. Subjects will have one or more clinical indications diagnostic of CLI such as: distal extremity pain at rest that requires the subject to use analgesics for >2 weeks; or peripheral ischemic ulcer(s); or areas of gangrene ; or non-healing ischemic ulcers AND
B. Subjects will have one or more of the following hemodynamic indicators of severe peripheral arterial occlusive disease:
I. Ankle brachial index < 0.45 II. Toe brachial index < 0.35 III. TcPO2 / TcO2 of < 40 mmHg. C. The subject is a poor candidate for standard revascularization treatment for peripheral arterial disease, based on inadequate bypass conduit, or unfavorable anatomy D. Age 18 to 80 years
Investigational Product : At D-8 250 ml of blood drawn from the patients for production of autologous EPCs or ACPs (VescellTM). On D0 ,at least 1.5 million ACPs with viability >75 % suspended in 30 ml sterile cell culture medium will be injected 1.5 cm deep and 1.5 apart by a 23 -gauge needle into the gastrocnemius muscle of the leg chosen (ischemic leg) for treatment. For injection planning a grid of 10X10 cm will be prepared and in each point 1 ml of ACPs suspension will be injected. The study consists of 4 periods: Screening ( D-14 to-9& D-8,Treatment(D0),Acute Safety follow-up (D1&D2),Chronic follow-up (D30 & D90)period
Evaluation criteria :
Safety : no.& duration of adverse event & serious adverse event Efficacy :Attenuate CLI patients symptoms (Rest pain,Pain-free walking distance,Ulcer size &Gangrene dimension and intensity)
Condition | Intervention | Phase |
---|---|---|
Peripheral Arterial Disease Critical Limb Ischemia |
Procedure: Angiogenic Cell Precursors (ACPs) or Vescell TM |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Study of Blood-Borne Autologous Angiogenic Cells Precursors Therapy in Patients With Critical Limb Ischemia |
Enrollment: | 6 |
Study Start Date: | January 2006 |
Study Completion Date: | March 2007 |
Six patients with Critical Limb Ischemia (CLI) or severe Peripheral Arterial Disease(PAD) will be enrolled, screened, treated with an injection of Blood-Borne Autologous Angiogenic Cell Precursors(ACPs) in to gastrocnemius of the ischemic leg by intramuscular under regional anesthesia. Following injection.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects will have one or more of the following hemodynamic indicators of severe peripheral arterial occlusive disease:
Exclusion Criteria:
Israel, P.O.B.4049,Ness Ziona | |
Dr. Valentin Fulga | |
Tel viv, P.O.B.4049,Ness Ziona, Israel, 74410 |
Principal Investigator: | Pramook Mutirangura, M.D. | Vascular Surgery Unit,Department of Surgery,Faculty of Medicine Siriraj Hospital,Mahidol University,BKK,Thailand |
Study ID Numbers: | TV-003, ACPs-CLI |
Study First Received: | August 30, 2007 |
Last Updated: | August 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00523731 History of Changes |
Health Authority: | Thailand: Food and Drug Administration |
Stem cells Rest pain claudication |
chronic ischemic or non-healing ulcers Angiogenesis no-option cases |
Peripheral Vascular Diseases Ulcer Vascular Diseases Pain Ischemia |
Pathologic Processes Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Ischemia |