Congestive Heart FailurePhase 1NCT00523224
ACPs Combined With CABG in Patients With CHF
A Phase 1 study testing Angiogenic Cell Precursors(ACPs) or Vescell TM and Angiogenic Cell Precusors in people with Congestive Heart Failure, run by TheraVitae Ltd. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Angiogenic Cell Precursors(ACPs) or Vescell TM and Angiogenic Cell Precusors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2006to Sep 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Theravitae Co.
Tel Viv, P.O. B 4049,Ness Ziona, 74410
Danny Belkin, Ph.D., +972-8-9409170, dbelkin@theravitae.com
Michael Belkin, Ph.D.,M.D., +972-3-530-2956, belkin@netvision.net.il
About this study
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 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.
Read more
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)
Read the 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).
- Conditions
- Congestive Heart Failure
- Being tested
- Angiogenic Cell Precursors(ACPs) or Vescell TM, Angiogenic Cell Precusors
- Keywords
- Stem cells, Coronary Artery Bypass grafting, Congestive Heart Failure, Coronary Artery Disease, Angiogenesis
- Medical subject headings
- Heart Failure, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiogenic Cell Precursors(ACPs) or Vescell TMProcedure or surgery
at least 1.5 million of ACPs per one time of treatment
Angiogenic Cell PrecusorsBiological
Stem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | open lable,single arm , intervention is Angiogenic Cell Precusors(ACPs) Receives: Procedure: Angiogenic Cell Precursors(ACPs) or Vescell TM; Biological: Angiogenic Cell Precusors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation criteria
Measured: 3 months
Safety : no.& duration of adverse event & serious adverse event
Measured: 3 months
Efficacy : EF , NYHA
Measured: 3 months
change from baseline to 1 & 3 months of NYHA, 6-minute walking test
Measured: 3 months
Change from baseline to 3 months of QoL(SF-36)
Measured: 3 months
Secondary outcomes (4)
Efficacy:%EF,NYHA
Measured: 3 months
change from baseline to 3 months of % LVEF by Echocardiography & C-MRI
Measured: 3 months
change from baseline to 3 months of % infracted scar area on C-MRI
Measured: 3 months
change from baseline to 3 months of QoL(SF-36)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startJan 2006
- Study completionSep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TheraVitae Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kitipan Visudharom, Ph.D.,M.D., Principal investigator, Bangkok Heart Hospital, 2 Soi Soonvijai 7,New Petchburi Rd.,Bangkok 10310 Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523224
- Sponsor's protocol ID
- TV-002
- Other IDs
- ACPs-CHF
- Status last verified
- May 2007
- First submitted
- 30 Aug 2007
- Last updated
- 31 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00523224
- Acronym / sponsor ID
- TV-002
- Conditions
- Congestive Heart Failure
- Keywords
- Stem cells, Coronary Artery Bypass grafting, Congestive Heart Failure, Coronary Artery Disease, Angiogenesis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- TheraVitae Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Sep 2007 (estimated)
- First posted
- 31 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Procedure: Angiogenic Cell Precursors(ACPs) or Vescell TM, Biological: Angiogenic Cell Precusorsopen lable,single arm , intervention is Angiogenic Cell Precusors(ACPs) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiogenic Cell Precursors(ACPs) or Vescell TMat least 1.5 million of ACPs per one time of treatment | Procedure or surgery | single arm |
| Angiogenic Cell PrecusorsStem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment | Biological | single arm |
Primary outcome
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kitipan Visudharom, Ph.D.,M.D. principal investigator
Bangkok Heart Hospital, 2 Soi Soonvijai 7,New Petchburi Rd.,Bangkok 10310 Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Angiogenic Cell Precursors(ACPs) or Vescell TM and Angiogenic Cell Precusors in people with Congestive Heart Failure, run by TheraVitae Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wannapa Kulwathanaporn, Master (++66-2-664-4290 ext. 141, wannapa@theravitae.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation criteria (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2007.