ACPs Combined With CABG in Patients With CHF
Primary Purpose
Congestive Heart Failure
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Angiogenic Cell Precursors(ACPs) or Vescell TM
Angiogenic Cell Precusors
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Stem cells, Coronary Artery Bypass grafting, Congestive Heart Failure, Coronary Artery Disease, Angiogenesis
Eligibility Criteria
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
Sites / Locations
- Theravitae Co.Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
open lable,single arm , intervention is Angiogenic Cell Precusors(ACPs)
Outcomes
Primary Outcome Measures
Evaluation criteria
Safety : no.& duration of adverse event & serious adverse event
Efficacy : EF , NYHA
change from baseline to 1 & 3 months of NYHA, 6-minute walking test
Change from baseline to 3 months of QoL(SF-36)
Secondary Outcome Measures
Efficacy:%EF,NYHA
change from baseline to 3 months of % LVEF by Echocardiography & C-MRI
change from baseline to 3 months of % infracted scar area on C-MRI
change from baseline to 3 months of QoL(SF-36)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00523224
Brief Title
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
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
TheraVitae Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. 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)
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Stem cells, Coronary Artery Bypass grafting, Congestive Heart Failure, Coronary Artery Disease, Angiogenesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
open lable,single arm , intervention is Angiogenic Cell Precusors(ACPs)
Intervention Type
Procedure
Intervention Name(s)
Angiogenic Cell Precursors(ACPs) or Vescell TM
Intervention Description
at least 1.5 million of ACPs per one time of treatment
Intervention Type
Biological
Intervention Name(s)
Angiogenic Cell Precusors
Intervention Description
Stem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment
Primary Outcome Measure Information:
Title
Evaluation criteria
Time Frame
3 months
Title
Safety : no.& duration of adverse event & serious adverse event
Time Frame
3 months
Title
Efficacy : EF , NYHA
Time Frame
3 months
Title
change from baseline to 1 & 3 months of NYHA, 6-minute walking test
Time Frame
3 months
Title
Change from baseline to 3 months of QoL(SF-36)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Efficacy:%EF,NYHA
Time Frame
3 months
Title
change from baseline to 3 months of % LVEF by Echocardiography & C-MRI
Time Frame
3 months
Title
change from baseline to 3 months of % infracted scar area on C-MRI
Time Frame
3 months
Title
change from baseline to 3 months of QoL(SF-36)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wannapa Kulwathanaporn, Master
Phone
++66-2-664-4290
Ext
141
Email
wannapa@theravitae.com
First Name & Middle Initial & Last Name or Official Title & Degree
David Czeiger, Ph.D.,M.D.
Phone
+972 54-208-0405
Email
dudyc@theravitae.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kitipan Visudharom, Ph.D.,M.D.
Organizational Affiliation
Bangkok Heart Hospital, 2 Soi Soonvijai 7,New Petchburi Rd.,Bangkok 10310 Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Theravitae Co.
City
Tel viv
State/Province
P.O. B 4049,Ness Ziona
ZIP/Postal Code
74410
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny Belkin, Ph.D.
Phone
+972-8-9409170
Email
dbelkin@theravitae.com
First Name & Middle Initial & Last Name & Degree
Michael Belkin, Ph.D.,M.D.
Phone
+972-3-530-2956
Email
belkin@netvision.net.il
12. IPD Sharing Statement
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ACPs Combined With CABG in Patients With CHF
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