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

Primary Purpose

Angina Pectoris

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Intracoronary administration of autologous ACPs

About this trial

This is an interventional treatment trial for Angina Pectoris focused on measuring Stem cells, Progenitor cells, Angina Pectoris, Heart Failure, Angiogenesis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with chronic stable angina on maximal medical therapy and an occluded coronary artery or bridging collaterals to a patent distal segment supplying an ischemic viable myocardial region as shown on Sestamibi scan. On coronary angiography, the occluded coronary artery or bridging collaterals must have a patent proximal segment of at least 30 mm with at least one side branch to enable the injection of the VesCellTM if the vessel remains occluded despite the attempted angioplasty efforts (prior to or during the study angiography).
Patients with occluded target coronary artery (with or without bridging collaterals) that could not be treated with PCI.
Patients are not candidates for or are not willing to undergo CABG surgery.
Age 18 to 80 years
Male or non-pregnant, non-lactating female
Ejection fraction >35% on Sestamibi
Sestamibi scan (myocardial perfusion) during exercise or dipyridamole, demonstrating regional reversible ischemia in an area relating to the occluded coronary artery.
Informed consent obtained and consent form signed

Exclusion Criteria:

Patients not satisfying the coronary angiography and Sestamibi criteria.
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)
STEMI during the preceding 3 months
PCI+stenting during the preceding three months
Significant valvular disease or after valve replacement
After heart transplantation
Cardiomyopathy
Renal failure (creatinine 10% above the upper limit according to the hospital normograms)
Hepatic failure
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 temperature above 38.40C for 2 consecutive days
Patient unlikely to be available for follow-up

Sites / Locations

Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

open label,single arm,intervention is Angiogenic Cell Precusors(ACPs)

Outcomes

Primary Outcome Measures

Safety of the procedure as manifested in the post treatment observation and

tests.

Secondary Outcome Measures

Changes from baseline to 1, 3 and 6 months in the CCS.

Changes from baseline to 1, 3 and 6 months of modified Bruce exercise test.

Changes from baseline to 6 months of exercise-induced ischemia on Sestamibi scan.

Changes from baseline to 6 months of %LVEF

Full Information

NCT ID

NCT00416663

First Posted

December 27, 2006

Last Updated

August 30, 2007

Sponsor

TheraVitae Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00416663

Brief Title

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

Official Title

A Study for Testing Efficacy and Safety of the Administration of Vescell(TM) (Blood-Borne Autologous Angiogenic Cell Precursors) to Alleviate Anginal Symptoms and Myocardial Ischemia in Severe Anginal Syndrome +/- Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Unknown status

Study Start Date

August 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

TheraVitae Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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 treatment or not willing or without option of undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). The use of ACPs aims to promote the formation of new vascularization and thus viable myocardial tissue.

Detailed Description

Ten adult patients with severe angina pectoris with or without heart failure and no therapeutic alternative will undergo screening and be treated with an injection of Angiogenic Cell Precursors (ACPs), contained in VesCell (TM). 250 ml of blood will be drawn from the patient and from this blood sample progenitor cells will be generated and differentiated into ACPs. The product will be administered into the obstructed coronary arteries using a catheter. Following injection, patients will be hospitalized for 24-48 hours in intensive care and later as required by their medical condition. Patients will return for follow up testing at one, three and six months following treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angina Pectoris

Keywords

Stem cells, Progenitor cells, Angina Pectoris, Heart Failure, Angiogenesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

single arm

Arm Type

Experimental

Arm Description

open label,single arm,intervention is Angiogenic Cell Precusors(ACPs)

Intervention Type

Procedure

Intervention Name(s)

Intracoronary administration of autologous ACPs

Other Intervention Name(s)

VescellTM

Intervention Description

Stem cells type:ACPs. At least 1.5 million of ACPs per one time of treatment

Primary Outcome Measure Information:

Title

Safety of the procedure as manifested in the post treatment observation and

Time Frame

6 months

Title

tests.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Changes from baseline to 1, 3 and 6 months in the CCS.

Time Frame

6 months

Title

Changes from baseline to 1, 3 and 6 months of modified Bruce exercise test.

Time Frame

6 months

Title

Changes from baseline to 6 months of exercise-induced ischemia on Sestamibi scan.

Time Frame

6 months

Title

Changes from baseline to 6 months of %LVEF

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with chronic stable angina on maximal medical therapy and an occluded coronary artery or bridging collaterals to a patent distal segment supplying an ischemic viable myocardial region as shown on Sestamibi scan. On coronary angiography, the occluded coronary artery or bridging collaterals must have a patent proximal segment of at least 30 mm with at least one side branch to enable the injection of the VesCellTM if the vessel remains occluded despite the attempted angioplasty efforts (prior to or during the study angiography). Patients with occluded target coronary artery (with or without bridging collaterals) that could not be treated with PCI. Patients are not candidates for or are not willing to undergo CABG surgery. Age 18 to 80 years Male or non-pregnant, non-lactating female Ejection fraction >35% on Sestamibi Sestamibi scan (myocardial perfusion) during exercise or dipyridamole, demonstrating regional reversible ischemia in an area relating to the occluded coronary artery. Informed consent obtained and consent form signed Exclusion Criteria: Patients not satisfying the coronary angiography and Sestamibi criteria. 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) STEMI during the preceding 3 months PCI+stenting during the preceding three months Significant valvular disease or after valve replacement After heart transplantation Cardiomyopathy Renal failure (creatinine 10% above the upper limit according to the hospital normograms) Hepatic failure 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 temperature 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

Astrid Rojansky, M.H.A.

Phone

+972-(0)2-6555956

astrid@szmc.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Danny Belkin, Ph.D.

Phone

+972-(0)8-9409170

Ext

dbelkin@theravitae.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan Tzivoni, MD

Organizational Affiliation

Director, Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shaare Zedek Medical Center

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

17052254

Citation

Porat Y, Porozov S, Belkin D, Shimoni D, Fisher Y, Belleli A, Czeiger D, Silverman WF, Belkin M, Battler A, Fulga V, Savion N. Isolation of an adult blood-derived progenitor cell population capable of differentiation into angiogenic, myocardial and neural lineages. Br J Haematol. 2006 Dec;135(5):703-14. doi: 10.1111/j.1365-2141.2006.06344.x.

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

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