ACPs Combined With CABG in Patients With CHF

Sponsor

TheraVitae Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00523224

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Detailed Description

Five CAD patients who required CABG with or without congestive heart failure will undergo screening and receiving of ACPs 's injection by direct intramuscular during CABG operation. After that,the patients will come to follow up with investigator at 1 and 3 months post surgery in order to evaluate safety and efficacy of stem cells therapy(ACPs).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Jan 1, 2006

Anticipated Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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 treatment Biological: Angiogenic Cell Precusors Stem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment

Arm

Intervention/Treatment

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 treatment

Biological: Angiogenic Cell Precusors

Stem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment

Outcome Measures

Primary Outcome Measures

Evaluation criteria [3 months]
Safety : no.& duration of adverse event & serious adverse event [3 months]
Efficacy : EF , NYHA [3 months]
change from baseline to 1 & 3 months of NYHA, 6-minute walking test [3 months]
Change from baseline to 3 months of QoL(SF-36) [3 months]

Secondary Outcome Measures

Efficacy:%EF,NYHA [3 months]
change from baseline to 3 months of % LVEF by Echocardiography & C-MRI [3 months]
change from baseline to 3 months of % infracted scar area on C-MRI [3 months]
change from baseline to 3 months of QoL(SF-36) [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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