ACPs Combined With CABG in Patients With CHF

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by TheraVitae Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
TheraVitae Ltd.
ClinicalTrials.gov Identifier:
NCT00523224
First received: August 30, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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)


Condition Intervention Phase
Congestive Heart Failure
Procedure: Angiogenic Cell Precursors(ACPs) or Vescell TM
Biological: Angiogenic Cell Precusors
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by TheraVitae Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 5
Study Start Date: January 2006
Estimated Study Completion Date: September 2007
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523224

Contacts
Contact: Wannapa Kulwathanaporn, Master ++66-2-664-4290 ext 141 wannapa@theravitae.com
Contact: David Czeiger, Ph.D.,M.D. +972 54-208-0405 dudyc@theravitae.com

Locations
Israel
Theravitae Co. Recruiting
Tel viv, P.O. B 4049,Ness Ziona, Israel, 74410
Contact: Danny Belkin, Ph.D.    +972-8-9409170    dbelkin@theravitae.com   
Contact: Michael Belkin, Ph.D.,M.D.    +972-3-530-2956    belkin@netvision.net.il   
Sponsors and Collaborators
TheraVitae Ltd.
Investigators
Principal Investigator: Kitipan Visudharom, Ph.D.,M.D. Bangkok Heart Hospital, 2 Soi Soonvijai 7,New Petchburi Rd.,Bangkok 10310 Thailand
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00523224     History of Changes
Other Study ID Numbers: TV-002, ACPs-CHF
Study First Received: August 30, 2007
Last Updated: August 30, 2007
Health Authority: Thailand: Food and Drug Administration

Keywords provided by TheraVitae Ltd.:
Stem cells
Coronary Artery Bypass grafting
Congestive Heart Failure
Coronary Artery Disease
Angiogenesis

Additional relevant MeSH terms:
Myocardial Ischemia
Heart Failure
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014