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Hypoplastic Left Heart - Healing Genes
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Hypoplastic Left Heart

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Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome

Phase I Safety Study of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Stage II Palliation of Hypoplastic Left Heart Syndrome


Phase 1

DESCRIPTION:

Doctors at 6 children’s medical centers in OK, PA, MN, CA, and CO are seeking pediatric patients with Hypoplastic Left Heart Syndrome (HLHS) to trial a cell-based regenerative therapy treatment of autologous umbilical cord blood (UCB) cells into the right ventricle of HLHS children undergoing a scheduled Glenn surgical procedure. The investigators hope this treatment using the individual’s own stem cell-rich umbilical cord blood can be used to strengthen the muscle of the right side of their heart. The treatment, a single injection to the heart at the time of their surgery, will then be followed up on at 1, 3, and 6 months and up to 2 years.


PATIENT MUST:

  • Up to 18 months of age
  • Have a bank of autologous cord blood product meeting study criteria
  • Mother’s serology test results are negative for HIV, Hepatitis B, and Hepatitis C
  • Have undergone Stage I surgical palliation and undergoing planned Stage II palliative Glenn surgery

THE STUDY INVOLVES:

  1. Prescreening to confirm eligibility of the patient to participate.
  2. Scheduled Stage II palliative Glenn surgery
  3. The treatment, a single injection to the heart at the time of their surgery, will then be followed up on at 1, 3, and 6 months and up to 2 years.

LOCATIONS AND CONTACTS:

The following locations are participating in the study:

Children’s Hospital Los Angeles in Los Angeles, CA. Map.

Children’s Hospital Colorado in Aurora, CO. Map.

Children’s Hospital of Minnesota in Minneapolis, MN. Map.

Mayo Clinic in Rochester, MN. Map.

Oklahoma University Children’s Hospital in Oklahoma City, OK. Map.

Children’s Hospital of Philadelphia in Philadelphia, PA. Map.

CONTACTS:

Karen S Miller  |  (507) 266-5510  |  [email protected]

Contact: Karen M Cavanaugh  |  (507) 538-8425  |  [email protected]

 

SPONSOR INFORMATION:

Timothy J. Nelson

University of Oklahoma

Children’s Hospital of Philadelphia

Children’s Hospitals and Clinics of Minnesota

Children’s Hospital Los Angeles

Children’s Hospital Colorado

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT01883076

 

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