ACPs Combined With CABG in Patients With CHF
|ClinicalTrials.gov Identifier: NCT00523224|
Recruitment Status : Unknown
Verified May 2007 by TheraVitae Ltd..
Recruitment status was: Recruiting
First Posted : August 31, 2007
Last Update Posted : August 31, 2007
Study title: A Study of Combined Coronary Artery Bypass Grafting (CABG) and Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients with Congestive Heart Failure due to Ischemic Heart Disease (ACPs-CHF) Principle Investigator: Kit V. Arom ,M.D.,Ph.D. Deputy Director, Chief Cardio-Thoracic Surgeon, Bangkok Heart Hospital Study objective : To determine the safety and efficacy of injection of blood-borne autologous ACPs into the non-graftable area of the heart of patients with congestive heart failure due to ischemic heart disease Its main goal is evaluation of feasibility and safety of the combined technique. The efficacy of the treatment will be tested in the following trial.
Study Design : Phase I , a single center, a non-randomized, open-label trial to test the safety, of intramyocardium transepicardium administration of ex vivo expanded autologous ACPs administered in combination with CABG operation in patients with congestive heart failure due to ischemic heart disease.
The study is a preliminary training study, under the supervision of the experienced Dr. Patel the U.S. principal investigator.
Study population :
Total expected no. of patients : 5 main selection criteria :
- Patients with or without signs of congestive heart failure due to ischemic heart disease who had maximal medical treatments. Not suitable to percutaneous intervention
- All patients must have a recent coronary angiogram. Patients must be able to have OPCAB and then have Angiogenic Cell Precursors(ACPs) in non-graftable and/or infraction regions
- Age 18 to 80 years
- MRI demonstrating areas of viable and non-viable myocardium Investigational Product : The patients will be blood drawn 250 ml at D-8 for producting autologous ACPs (VescellTM), On D0 ,at least 1.5 million ACPs with viability >75 % supended in 15 ml sterile cell culture medium will be injected 1 cm apart using a 23 gauge angled needle in 30 spots (0.5 ml /point) to the same patients by direct intramuscular approach at LV during CABG.
The study consists of 4 periods: Screening ( D-14 to-9& D-8,Treatment(D0),Acute Safety follow-up (D1-2& D5-discharge),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 :NYHA, 6-minute walking test ,% LVEF by Echocardiography & C-MRI, % infracted scar area on C-MRI , Pro-BNP & 3 months of QoL(SF-36)
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure||Procedure: Angiogenic Cell Precursors(ACPs) or Vescell TM Biological: Angiogenic Cell Precusors||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Combined Coronary Artery Bypass Grafting (CABG) and Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Congestive Heart Failure Due to Ischemic Heart Disease|
|Study Start Date :||January 2006|
|Estimated Study Completion Date :||September 2007|
Experimental: single arm
open lable,single arm , intervention is Angiogenic Cell Precusors(ACPs)
Procedure: Angiogenic Cell Precursors(ACPs) or Vescell TM
at least 1.5 million of ACPs per one time of treatmentBiological: Angiogenic Cell Precusors
Stem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment
- Evaluation criteria [ Time Frame: 3 months ]
- Safety : no.& duration of adverse event & serious adverse event [ Time Frame: 3 months ]
- Efficacy : EF , NYHA [ Time Frame: 3 months ]
- change from baseline to 1 & 3 months of NYHA, 6-minute walking test [ Time Frame: 3 months ]
- Change from baseline to 3 months of QoL(SF-36) [ Time Frame: 3 months ]
- Efficacy:%EF,NYHA [ Time Frame: 3 months ]
- change from baseline to 3 months of % LVEF by Echocardiography & C-MRI [ Time Frame: 3 months ]
- change from baseline to 3 months of % infracted scar area on C-MRI [ Time Frame: 3 months ]
- change from baseline to 3 months of QoL(SF-36) [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523224
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|Principal Investigator:||Kitipan Visudharom, Ph.D.,M.D.||Bangkok Heart Hospital, 2 Soi Soonvijai 7,New Petchburi Rd.,Bangkok 10310 Thailand|