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Hypertension - Healing Genes
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Hypertension

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Allogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therapy (ALPHA)

A Phase I Study of the Safety and Feasibility of Central Intravenous Delivery of Allogeneic Human Cardiosphere-Derived Stem Cells in Patients With Pulmonary Arterial Hypertension ALPHA Trial


Phase 1

DESCRIPTION

Cedars Sinai Medical Center is recruiting patients for a two-part trial of an investigatory biologic treatment of Pulmonary Arterial Hypertension, or PAH, in the form of stem cells grown from donated human heart tissue. The researchers believe these donor (allogeneic) cells have the potential to help reduce immune system dysfunction in PAH patients.

The first phase of the trial (1a) requires the investigational drug to be given at different doses per patient, with treatments delivered via central line. For 72 hours after the infusion, the patients will be closely observed under hospital care, then be followed for up to a year after.


PATIENT MUST:

  • Be 18 to 75 years of age
  • Have a confirmed diagnosis of one of several types of PAH
  • Not be pregnant or breastfeeding

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility and safety of the patient to participate.
  2. A single infusion into a primary vein of the heart to deliver the trial therapy.
  3. After observation, the patient will be discharged and keep in contact to report any adverse reactions.

LOCATIONS AND CONTACTS:

The study site is at the Cedars-Sinai Medical Center. Map.

Contacts:

Ellie Zhu, MBBS, MS  |  310-423-3081  |  [email protected]

Tracey Early, BA, MA, CCRP  |  310-423-1231  |  [email protected]

SPONSOR INFORMATION:

Cedars-Sinai Medical Center

California Institute for Regenerative Medicine (CIRM)

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03145298

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