ACPs Combined With CABG in Patients With CHF

2014-08-27 03:36:27 | BioPortfolio


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)


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

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Congestive Heart Failure


Angiogenic Cell Precursors(ACPs) or Vescell TM, Angiogenic Cell Precusors


Theravitae Co.
Tel viv
P.O. B 4049,Ness Ziona




TheraVitae Ltd.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:36:27-0400

Clinical Trials [7100 Associated Clinical Trials listed on BioPortfolio]

Vescell(TM) for the Treatment of Patients With Severe Anginal Syndrome With or Without Heart Failure

Evaluation of an intracoronary injection of ex-vivo generated autologous Angiogenic Cells Precursors (ACPs) to treat patients suffering from severe angina not responsive to maximal drug tr...

Blood Derived Autologous Angiogenic Cell Precursor Therapy in Patients With Critical Limb Ischemia (ACP-CLI)

The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb...

ACPs in Severe PAD/CLI by Direct Intramuscular Injection

Study title: A Study of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients with Critical Limb Ischemia ( ACPs-CLI ) Principle Investigator: Assoc.Prof. Pramook Mutira...

Analysis of Angiogenic Factor Levels in Eyes With Diabetic Retinopathy

This study was conducted to investigate the levels of angiogenic factors and anti-angiogenic factors in the aqueous humor of patients with diabetic retinopathy.

Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Progresses During or After Prior Systemic Anti-angiogenic Regimen

The primary objective of this study is to evaluate the incidence of high-grade (i.e. Grade 3-4 and Grade 5 of CTCAE v4.0) adverse reactions of interest in patients with metastatic RCC who ...

PubMed Articles [26087 Associated PubMed Articles listed on BioPortfolio]

The Functional Implications of Endothelial Gap Junctions and Cellular Mechanics in Vascular Angiogenesis.

Angiogenesis-the sprouting and growth of new blood vessels from the existing vasculature-is an important contributor to tumor development, since it facilitates the supply of oxygen and nutrients to ca...

Circulating angiogenic cell response to sprint interval and continuous exercise.

Although commonly understood as immune cells, certain T lymphocyte and monocyte subsets have angiogenic potential, contributing to blood vessel growth and repair. These cells are highly exercise respo...

The role of purinergic P2Y receptor blockers on the angiogenic properties of endothelial cells: an in vitro study.

Pharmacotherapy with agents that inhibit platelet function has proven to be effective in the treatment of acute coronary syndrome. Proper re-endothelization after angioplasty prevents adverse cardiova...

Enhanced TGF-β Signaling Contributes to the Insulin-Induced Angiogenic Responses of Endothelial Cells.

Angiogenesis, the development of new blood vessels, is a key process in disease. We reported that insulin promotes translocation of transforming growth factor β (TGF-β) receptors to the plasma membr...

Matrix-assisted Cell Transplantation for Tissue Vascularization.

Cell therapy offers much promise for the treatment of ischemic diseases by augmenting tissue vasculogenesis. Matrix-assisted cell transplantation (MACT) has been proposed as a solution to enhance cell...

Medical and Biotech [MESH] Definitions

Intercellular signaling peptides and proteins that regulate the proliferation of new blood vessels under normal physiological conditions (ANGIOGENESIS, PHYSIOLOGICAL). Aberrant expression of angiogenic proteins during disease states such as tumorigenesis can also result in PATHOLOGICAL ANGIOGENESIS.

A family of structurally-related angiogenic proteins of approximately 70 kDa in size. They have high specificity for members of the TIE RECEPTOR FAMILY.

Agents that induce or stimulate the PHYSIOLOGIC ANGIOGENESIS process. This is caused by a number of ANGIOGENIC PROTEINS.

Agents that modulate the PHYSIOLOGIC ANGIOGENESIS process. This is accomplished by endogenous ANGIOGENIC PROTEINS and a variety of other chemicals and pharmaceutical agents.

Differentiation antigens expressed on B-lymphocytes and B-cell precursors. They are involved in regulation of B-cell proliferation.

More From BioPortfolio on "ACPs Combined With CABG in Patients With CHF"

Quick Search


Searches Linking to this Trial