- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00523224
ACPs Combined With CABG in Patients With CHF
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 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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Wannapa Kulwathanaporn, Master
- Phone Number: 141 ++66-2-664-4290
- Email: wannapa@theravitae.com
Study Contact Backup
- Name: David Czeiger, Ph.D.,M.D.
- Phone Number: +972 54-208-0405
- Email: dudyc@theravitae.com
Study Locations
-
-
P.O. B 4049,Ness Ziona
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Tel viv, P.O. B 4049,Ness Ziona, Israel, 74410
- Recruiting
- Theravitae Co.
-
Contact:
- Danny Belkin, Ph.D.
- Phone Number: +972-8-9409170
- Email: dbelkin@theravitae.com
-
Contact:
- Michael Belkin, Ph.D.,M.D.
- Phone Number: +972-3-530-2956
- Email: belkin@netvision.net.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion 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
- Male or non-pregnant, non-lactating female
- MRI demonstrating areas of viable and non-viable myocardium
- Informed consent obtained and consent form signed
Exclusion Criteria:
- Prior Cardiac Surgery or Heart Transplantation
- Patient who received blood transfusions during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
- Inability to communicate (that may interfere with the clinical evaluation of the patient)
- Acute Myocardial infarction < 6 days from acute event
- Significant valvular disease or after valve replacement
- Left Ventricular Aneurysm
- Collagen tissue disease
- History of Prior Radiation Exposure
- History of alcohol or drug abuse within 3 months of screening
- Renal failure (creatinine > 2 mg/dl) or Hemodialysis
- Hepatic failure or History of Liver Cirrhosis
- Females who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study.
- Anemia (lower than 11mg/dl.hemoglobin for female and lower than 12 mg/dl for male)
- Abnormal coagulation tests normal [platelets, PT (INR), PTT]
- Stroke within the preceding 3 years
- Malignancy within the preceding 3 years
- Concurrent chronic or acute infectious disease
- Severe concurrent medical disease (e.g., septicemia, HIV-1,2/HBV/HCV infections, insulin-dependent diabetes mellitus, systemic lupus erythematosus, multiple sclerosis, amyotrophic lateral sclerosis)
- Chronic immunomodulating or cytotoxic drugs treatment
- Patients who have rectal temp. above 38.40C for 2 consecutive days
- Patient unlikely to be available for follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single arm
open lable,single arm , intervention is Angiogenic Cell Precusors(ACPs)
|
at least 1.5 million of ACPs per one time of treatment
Stem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation criteria
Time Frame: 3 months
|
3 months
|
Safety : no.& duration of adverse event & serious adverse event
Time Frame: 3 months
|
3 months
|
Efficacy : EF , NYHA
Time Frame: 3 months
|
3 months
|
change from baseline to 1 & 3 months of NYHA, 6-minute walking test
Time Frame: 3 months
|
3 months
|
Change from baseline to 3 months of QoL(SF-36)
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy:%EF,NYHA
Time Frame: 3 months
|
3 months
|
change from baseline to 3 months of % LVEF by Echocardiography & C-MRI
Time Frame: 3 months
|
3 months
|
change from baseline to 3 months of % infracted scar area on C-MRI
Time Frame: 3 months
|
3 months
|
change from baseline to 3 months of QoL(SF-36)
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kitipan Visudharom, Ph.D.,M.D., Bangkok Heart Hospital, 2 Soi Soonvijai 7,New Petchburi Rd.,Bangkok 10310 Thailand
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TV-002
- ACPs-CHF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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