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Heart Disease - Healing Genes
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Heart Disease

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Stem Cell Heart Injections During Laser Revascularization Surgery for Treatment of Chronic Ischemic Heart Disease

Prospective Controlled Trial of Intra-Myocardial Infusion of Bone Marrow Derived Autologous CD133+ Selected Cells During Trans-Myocardial Laser Revascularization (TMR) in Patients With Chronic Ischemic Heart Disease


Phase 1
DESCRIPTION:

Doctors at the University of Kentucky seek participants in a clinical trial of stem cell heart injections in patients receiving trans-myocardial laser revascularization (TMR). The stem cells will be derived from the patient’s own bone marrow, and screened for a particular form of stem cells known to grow into myocardial (heart muscle) tissue, then injected to the target heart tissue with a goal of improving heart function.

The investigatory treatment will happen during the TMR laser treatment, with single injections at the site of each laser channel (~10-20 injections). Prior recovery of the bone marrow aspirate and follow up at baseline, 3, 6, and 12 months is also required.


PATIENT MUST:

  • Be 18 years of age or older
  • Meet study criteria regarding the severity of their chronic ischemic heart disease

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility and safety of the patient to participate.
  2. Bone marrow recovery surgery to aspirate bone marrow and retrieve stem cells.
  3. TMR laser treatment, with single injections of the select stem cells at the site of each laser channel (~10-20 injections).
  4. Follow up at baseline, 3, 6, and 12 months.

LOCATIONS AND CONTACTS:

The study site is at the University of Kentucky Healthcare in Lexington, KY, (Map).

Contact: Connie Dampier, RN, MPA  |  859-323-1781  |  [email protected]

Contact: Michael Sekela, MD  |  859-323-6494  |  [email protected]

 

SPONSOR INFORMATION:

Michael Sekela

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03043742

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