Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
5 participants
INTERVENTIONAL
2006-01-31
2007-09-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single arm
open lable,single arm , intervention is Angiogenic Cell Precusors(ACPs)
Angiogenic Cell Precursors(ACPs) or Vescell TM
at least 1.5 million of ACPs per one time of treatment
Angiogenic Cell Precusors
Stem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment
Interventions
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Angiogenic Cell Precursors(ACPs) or Vescell TM
at least 1.5 million of ACPs per one time of treatment
Angiogenic Cell Precusors
Stem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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TheraVitae Ltd.
INDUSTRY
Principal Investigators
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Kitipan Visudharom, Ph.D.,M.D.
Role: PRINCIPAL_INVESTIGATOR
Bangkok Heart Hospital, 2 Soi Soonvijai 7,New Petchburi Rd.,Bangkok 10310 Thailand
Locations
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Theravitae Co.
Tel Viv, P.O. B 4049,Ness Ziona, Israel
Countries
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Central Contacts
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Facility Contacts
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Danny Belkin, Ph.D.
Role: primary
Michael Belkin, Ph.D.,M.D.
Role: backup
Other Identifiers
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ACPs-CHF
Identifier Type: -
Identifier Source: secondary_id
TV-002
Identifier Type: -
Identifier Source: org_study_id