Summary of Pre-Clinical Data – Heart Muscle Regeneration

Members of Bioheart Research Team

  1. Doris Taylor, Ph.D. – Duke University

    Work began: 1991

    Type of Work: Autologous Myoblast Cell Therapy (regenerative satellite cells)

    Additional Additives Being Studied: F.G.F., V.E.G.F, N.O.S.

    Basic Procedure: Harvest skeletal muscle from thigh, separate immature myoblasts, culture to 10 billion cells, reinject into myocardium with needle catheter

    No. of Animals Completed: Approximately 400

    Type of Animals: Rabbits and Pigs

    Injury Model: Cryoinfarction and Ligation Infarctions

    Current Results: 50-70% improvement of cardiac performance

  2. Ray Chiu, M.D. – McGill University

    Work Began: 1990

    Type of Work: Autologous Bone Marrow Stromal Cell Derived Residual Cycling Stem Cells

    Additional Additives Being Studied: V.E.G.F., N.O.S.

    Basic Procedure: Harvest bone marrow biopsy, separate out residual cycling stem cells, culture, reinject into myocardium

    No. of Animals Completed: Approximately 40

    Type of Animals: Pigs, Dogs, Rabbits

    Injury Model: Ligation Infarction, Balloon Infarction

    Current Results: 50% improvement of cardiac performance

    Latest Work: Transvecting Myoblasts with Growth Factors and Nitric Oxide Synthase

  3. Peter Law, Ph.D., M.D. – Cell Therapy Foundation, Memphis

    Work Began: 1975

    Type of Work: Allogenic Myoblast Cell Therapy

    Additional Additives Being Studied: N.O.S., Electrical/Vibrational Stimulation

    Basic Procedure: Harvest myoblasts from genotyped foreign donor, separate out immature myoblasts, culture to 50 billion cells, place in special serum free media, put on shelf, reinject immediately after infarction

    No. of Animals Completed (OUTSIDE OF HEART): 600

    No. of Human Cases for Repair of Muscle (OUTSIDE OF HEART): 200 Under Phase II I.N.D. moving to Phase III

    Types of Animals: Rabbits and Pigs

    Injury Model: None in most animals, Recently Ligation Infarction

    Current Results: Muscle Function Substantially Improved, No Safety Problems

    Latest Work: Using Cell Fusion Properties of Myoblasts in Culture with Cardiomyocytes Harvested From Patient

  4. Dan Burkhoff, Ph.D., M.D. – Columbia University New York

    Work Began: 199?

    Type of Work: Heart Failure Animal Model

    Additional Additives Being Studied: Left Ventricular Assist Device

    Basic Procedure: Use glass microsphere injections of many weeks to create simulation of heart failure in dog

    No. of Animals Completed: ? NEW working with Bioheart.

    Type of Animals: Dogs

    Type of Injury: Glass microspheres slowly create ischemia over weeks - patchy

    Current Results: Best Animal Model Simulation of Heart Failure Available

    Latest Work: Using mixture of myoblasts, mesenchymal stem cells, growth factors and N.O.S. with L.V.A.D. to effect improvement of cardiac function – also basic study of safety of autologous myoblast cell therapy

  5. Syde Taheri, M.D. – University of Buffalo – Millard Fillmore Hospital

    Work Began: 1975

    Type of Work: Use of Omentum as Blood Supply to Infarcted Heart

    Additional Additives Being Studied: Skeletal Muscle Myoblasts

    Basic Procedure: With surgical or laproscopic means moving omentum and reattach to infarcted area of heart to improve blood supply and stitch in place patch of skeletal muscle myoblasts

    No. of Animals: 22

    Type of Animals: Dogs, Rabbits

    Type of Injury: Ligation infarction of L.A.D.

    Current Results: Substantial improvement of cardiac function

    Latest Work: Laproscopic means of moving omentum to infarction

  6. Stu Williams, Ph.D. – University of Arizona Health Sciences

    Work Began: 1980

    Type of Work: Endothelial cell sodding, tissue engineering, delivery stystem testing, angiogenesis

    Additional Additives Being Studied: Microvascular Fat

    Basic Procedure: Harvest autologous endothelial cells – reinject into damaged organ. Also feasibility test comparison of various delivery systems.

    No. of Animals: 30+, 2 for delivery systems

    Type of Animals: Pigs

    Type of Injury: Ligation infarction

    Current Results: Improved Angiogenesis compared to needle mechanical irritation alone, delivery systems – endovascular, surgical and laproscopic proven feasibility.

    Latest Work: Laproscopic means of injecting into myocardium

  7. Stephen Ellis, M.D. – Cleveland Clinic (agreement tentative still being finalized)

    Work Began: New

    Type of Work: Testing of additives to mix with immature myoblasts or stem cells to improve angiogenesis and myogenesis ie; NOS, Angiopoiten 1, SERCA 2, FGF, VEGF. Also work related to maximizing immortalized or hibernating cells for improvement of heart function.

    Basic Procedure: Controlled ligation infarction, injection of cells directly into


    Type of Animals: Dogs and Pigs

    No. of Animals: New

    Type of Injury: Controlled ligation infarction

    Current Results: New

    Latest Work: Determining 12 candidates additives for testing to improve angiogenesis and myogenesis

  8. Sam Ahn, M.D. – U.C.L.A.

    Work Began: March 2000

    Type of Work: Development of Laproscopic System for injecting cells into myocardium, moving omentum blood supply and transplanting viable cardiac myocytes into lesion.

    Basic Procedure: 4 5mm holes in chest and abdomen provide laproscopic access to heart. One lung is partially collapsed. System is used to inject cells, move omentum blood cell and transplant cardiomyocytes.

    Type of Animals: Pigs

    No. of Animals: 2

    Type of Injury: Controlled ligation infarction

    Current Results: Feasibility proven

    Latest Work: Biopsy and injection method improvement for transplantation of cardiomyocytes from viable heart to infracted lesion.


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Cardiovascular Healthcare
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