ALPHA: Pulmonary Arterial Hypertension & Cardiosphere-Derived Allogeneic Stem Cells

Condition: Idiopathic, heritable, connective tissue disease-associated and HIV-associated pulmonary arterial hypertension

Eligibility

Key Inclusion Criteria

  • Confirmed clinical diagnosis of IPAH, HPAH, PAH-CTD, PAH-HIV
  • NYHA Functional Class: II or III
  • 18-75 years old

Key Exclusion Criteria

  • Diagnosis of PAH other than IPAH, HPAH, PAH-CTD or PAH-HIV
  • Pulmonary capillary wedge pressure or LVEDP >15 mm Hg
  • Pregnant or nursing

Full Study Name

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 (Added Clinical Protocol to IND #16686) (IRB no. 47868)

Phase

Phase I

Summary

This study focuses on patients with pulmonary arterial hypertension (PAH) from the following subgroups: idiopathic PAH (IPAH), heritable PAH (HPAH), PAH associated with connective tissue disease (PAH-CTD) and PAH associated with HIV (PAH-HIV). The study is designed to evaluate the investigational use of a biologic product called CAP-1002. CAP-1002 consists largely of heart stem cells ("CDCs") grown from donated tissue from human heart muscle. The purpose of the study is to determine the maximum feasible dose and safety of CAP-1002 administered by central intravenous infusion (IV line) in PAH patients belonging to one of the subgroups listed above who have been started on PAH-specific medications. CAP-1002 will be used in addition to the participant’s regular treatment regimen.

Financial disclosure: Eduardo Marbán, MD, who is the head of the Cedars Sinai Heart Institute, invented the methods used to grow and expand stem cells from heart biopsies, which are the methods used in the development of the study drug. Cedars-Sinai filed applications for patents regarding those inventions, which have been licensed to Capricor by the sponsor.


Principal Investigator

Michael Lewis, MD

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