ACPs in Severe PAD/CLI by Direct Intramuscular Injection
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 ,total follow-up of each case is 3 months.
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)
Peripheral Arterial Disease
Critical Limb Ischemia
Procedure: Angiogenic Cell Precursors (ACPs) or Vescell TM
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study of Blood-Borne Autologous Angiogenic Cells Precursors Therapy in Patients With Critical Limb Ischemia|
- Safety [ Time Frame: 3 months ]
- Evaluate the safety of ACPs intramuscular injection [ Time Frame: 3 months ]
- Efficacy [ Time Frame: 3 months ]
- Attenuate CLI patients symptoms as [ Time Frame: 3 months ]
- Rest pain [ Time Frame: 3 months ]
- Pain-free walking distance [ Time Frame: 3 months ]
- Ulcer size [ Time Frame: 3 months ]
- Gangrene dimension and intensity [ Time Frame: 3 months ]
- Obtain evidence for improvement of tissue perfusion due to ACPs injection [ Time Frame: 3 months ]
- Reduction of CLI patients hospitalization time. [ Time Frame: 3 months ]
- Decrease CLI patient amputation rate. [ Time Frame: 3 months ]
|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.
|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|