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| ID | Type | Description | Link |
|---|---|---|---|
| ACPs-CHF |
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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 :
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)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | open lable,single arm , intervention is Angiogenic Cell Precusors(ACPs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiogenic Cell Precursors(ACPs) or Vescell TM | Procedure | at least 1.5 million of ACPs per one time of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation criteria | 3 months | |
| Safety : no.& duration of adverse event & serious adverse event | 3 months | |
| Efficacy : EF , NYHA | 3 months | |
| change from baseline to 1 & 3 months of NYHA, 6-minute walking test | 3 months | |
| Change from baseline to 3 months of QoL(SF-36) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:%EF,NYHA | 3 months | |
| change from baseline to 3 months of % LVEF by Echocardiography & C-MRI | 3 months | |
| change from baseline to 3 months of % infracted scar area on C-MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wannapa Kulwathanaporn, Master | Contact | ++66-2-664-4290 | 141 | wannapa@theravitae.com |
| David Czeiger, Ph.D.,M.D. | Contact | +972 54-208-0405 | dudyc@theravitae.com |
| Name | Affiliation | Role |
|---|---|---|
| Kitipan Visudharom, Ph.D.,M.D. | Bangkok Heart Hospital, 2 Soi Soonvijai 7,New Petchburi Rd.,Bangkok 10310 Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theravitae Co. | Recruiting | Tel Viv | P.O. B 4049,Ness Ziona | 74410 | Israel |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
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| Angiogenic Cell Precusors | Biological | Stem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment |
|
| 3 months |
| change from baseline to 3 months of QoL(SF-36) | 3 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |