Trials / Unknown
UnknownNCT00416663
Vescell(TM) for the Treatment of Patients With Severe Anginal Syndrome With or Without Heart Failure
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
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- TheraVitae Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Intracoronary administration of autologous ACPs | Stem cells type:ACPs. At least 1.5 million of ACPs per one time of treatment |
Timeline
- Start date
- 2007-08-01
- Completion
- 2007-08-01
- First posted
- 2006-12-28
- Last updated
- 2007-09-03
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT00416663. Inclusion in this directory is not an endorsement.