The ALPHA phase 1 study: pulmonary ArteriaL hypertension treated with CardiosPHere-Derived allogeneic stem cells.

Authors:
Lewis MI; Shapiro S; Oudiz RJ; Nakamura M; Geft D and 10 more

Journal:
EBioMedicine

Publication Year: 2023

DOI:
10.1016/j.ebiom.2023.104900

PMCID:
PMC10879003

PMID:
38092579

Journal Information

Full Title: EBioMedicine

Abbreviation: EBioMedicine

Country: Unknown

Publisher: Unknown

Language: N/A

Publication Details

Subject Category: Genetics, Medical

Available in Europe PMC: Yes

Available in PMC: Yes

PDF Available: No

Transparency Score
5/6
83.3% Transparent
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Evidence found in paper:

"the mass spectrometry data are available in the massive repository (msv000093323).; the mass spectrometry data are available in the massive repository (msv000093323)."

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Evidence found in paper:

"Declaration of interests MIL: PI on CIRM grant that funded this study. No relevant conflicts of interest to report. SS: Site PI for PAH research with the following companies: Medtronic, United therapeutics, Pharmosa, Liquidia, Gossamer, Aerovate, Lung Rx. RJO: Research funding: Actelion/JnJ/Janssen, Acceleron/Merck, Gossamer Bio, Insmed, Liquidia, United Therapeutics. Speaker bureau: Janssen, United Therapeutics. Advisory: Actelion/JnJ/Janssen, Acceleron/Merck, Aerami, Aerovate, Gossamer Bio, Insmed, Liquidia, OptumRx, Respira, United Therapeutics. MN: No relevant conflicts of interest to report. DG: No relevant conflicts of interest to report. YM: Site PI for PAH research with Aerovate Therapeutics, Mallickrodt, Penumbra. AH: Site PI for PAH research with the following companies: Bayer, United therapeutics/Lung Rx LLC, Insmed Incorporated, Acceleron Pharma Inc. Bayer (Advisory board, consulting). VFT: VP medical affairs, Inara Medical Inc. TDH: No relevant conflicts of interest to report. PA: No relevant conflicts of interest to report. RS: Consultant: Aria; Third Pole; United Therapeutics; Janssen; Liquidia; Insmed; Acceleron; Funding for clinical studies: United Therapeutics; Altavant; Aerovate; Acceleron; Bellerophon. JM: No relevant conflicts of interest to report. OK: No relevant conflicts of interest to report. JvE: No relevant conflicts of interest to report. EM: Owns founder's equity in Capricor Therapeutics."

Evidence found in paper:

"The study was funded by the 10.13039/100000900California Institute for Regenerative Medicine (Project Number: CLIN2-09444). The following investigators were part of the ALPHA Phase I clinical study grant. Dr. Michael Lewis role: Principal Investigator; the following were Co-Investigators: Shelley Shapiro, Ronald J. Oudiz, Mamoo Nakamura, Dael Geft, Antoine Hage, Victor F. Tapson, Timothy D. Henry, Rajan Saggar, Eduardo Marbán. We gratefully acknowledge the expansive involvement and support of the Project Manager Russell Haber MS as well as the Research Coordinators and Nurses (Ellie Zhu MBChB, MS, Maria Thottam BS, Ayda Aliyari BS, Tracey Early MA, Wendy Hill NP). We also acknowledge the Cedars IRB/CRO program (Leah Silbert, Hannah Coleman, Kristina Reuckert). We acknowledge in part funding support for statistical analyses (NIH National Center for Advancing Translational Science (NCATS) UCLA CTSI Grant Number UL1TR001881). We are most grateful to all the patients screened and enrolled and to their referring physicians. We acknowledge the assistance of the Yale Research group and the members of the DSMB. We are also most grateful to our CIRM grant official Lisa Kadyk, PhD and the CIRM advisory committee who assisted us throughout the study."

Evidence found in paper:

"This study was approved by the Cedars-Sinai Institutional Review Board's (IRB) Stem Cell Research Oversight Committee. The study is registered with ClinicalTrials.gov (NCT03145298) and is FDA authorized (IND #16686). All subjects underwent the full process of informed consent with IRB approved informed consent forms signed and retained."

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Paper is freely available to read
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Last Updated: Aug 05, 2025