ACPs Combined With CABG in Patients With CHF

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00523224
• Other study ID #: TV-002
• Secondary ID: ACPs-CHF
• Status: Recruiting
• Phase: Phase 1
• First received: August 30, 2007
• Last updated: August 30, 2007
• Start date: January 2006
• Est. completion date: September 2007

Study information

• Verified date: May 2007
• Source: TheraVitae Ltd.
• Contact: Wannapa Kulwathanaporn, Master
• Phone: ++66-2-664-4290
• Email: wannapa[@]theravitae.com
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Israel	Theravitae Co.	Tel viv	P.O. B 4049,Ness Ziona

Sponsors (1)

Lead Sponsor	Collaborator
TheraVitae Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation criteria		3 months
Primary	Safety : no.& duration of adverse event & serious adverse event		3 months
Primary	Efficacy : EF , NYHA		3 months
Primary	change from baseline to 1 & 3 months of NYHA, 6-minute walking test		3 months
Primary	Change from baseline to 3 months of QoL(SF-36)		3 months
Secondary	Efficacy:%EF,NYHA		3 months
Secondary	change from baseline to 3 months of % LVEF by Echocardiography & C-MRI		3 months
Secondary	change from baseline to 3 months of % infracted scar area on C-MRI		3 months
Secondary	change from baseline to 3 months of QoL(SF-36)		3 months