Clinical trial NCT00523224: ACPs Combined With CABG in Patients With CHF
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Congestive Heart Failure
Keywords: Stem cells
Coronary Artery Bypass grafting
Congestive Heart Failure
Coronary Artery Disease
Angiogenesis
Lead sponsor: TheraVitae Ltd.
Sponsor class: INDUSTRY
First posted: 2007-08-31
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 :

1. Patients with or without signs of congestive heart failure due to ischemic heart disease who had maximal medical treatments. Not suitable to percutaneous intervention
2. 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
3. Age 18 to 80 years
4. 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)

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).

Eligibility criteria: Inclusion Criteria:

1. Patients with or without signs of congestive heart failure due to ischemic heart disease who had maximal medical treatments. Not suitable to percutaneous intervention
2. 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
3. Age 18 to 80 years
4. Male or non-pregnant, non-lactating female
5. MRI demonstrating areas of viable and non-viable myocardium
6. Informed consent obtained and consent form signed

Exclusion Criteria:

1. Prior Cardiac Surgery or Heart Transplantation
2. Patient who received blood transfusions during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
3. Inability to communicate (that may interfere with the clinical evaluation of the patient)
4. Acute Myocardial infarction \< 6 days from acute event
5. Significant valvular disease or after valve replacement
6. Left Ventricular Aneurysm
7. Collagen tissue disease
8. History of Prior Radiation Exposure
9. History of alcohol or drug abuse within 3 months of screening
10. Renal failure (creatinine \> 2 mg/dl) or Hemodialysis
11. Hepatic failure or History of Liver Cirrhosis
12. Females who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study.
13. Anemia (lower than 11mg/dl.hemoglobin for female and lower than 12 mg/dl for male)
14. Abnormal coagulation tests normal \[platelets, PT (INR), PTT\]
15. Stroke within the preceding 3 years
16. Malignancy within the preceding 3 years
17. Concurrent chronic or acute infectious disease
18. 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)
19. Chronic immunomodulating or cytotoxic drugs treatment
20. Patients who have rectal temp. above 38.40C for 2 consecutive days
21. Patient unlikely to be available for follow-up

Primary outcomes:
measure: Evaluation criteria
timeFrame: 3 months
measure: Safety : no.& duration of adverse event & serious adverse event
timeFrame: 3 months
measure: Efficacy : EF , NYHA
timeFrame: 3 months
measure: change from baseline to 1 & 3 months of NYHA, 6-minute walking test
timeFrame: 3 months
measure: Change from baseline to 3 months of QoL(SF-36)
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy:%EF,NYHA
timeFrame: 3 months
measure: change from baseline to 3 months of % LVEF by Echocardiography & C-MRI
timeFrame: 3 months
measure: change from baseline to 3 months of % infracted scar area on C-MRI
timeFrame: 3 months
measure: change from baseline to 3 months of QoL(SF-36)
timeFrame: 3 months
Other outcomes:
Locations:
city: Tel viv
country: Israel
facility: Theravitae Co.
state: P.O. B 4049,Ness Ziona
Study officials:
affiliation: Bangkok Heart Hospital, 2 Soi Soonvijai 7,New Petchburi Rd.,Bangkok 10310 Thailand
name: Kitipan Visudharom, Ph.D.,M.D.
role: PRINCIPAL_INVESTIGATOR
References: