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Allogeneic Human Cardiosphere-Derived Stem Cells for Pulmonary Arterial Hypertension (ALPHA Trial)

Phase 1
Waitlist Available
Led By Michael I Lewis, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NYHA Functional Class: II or III
The subjects must be on PAH-specific therapies for at least 4 months and on a stable dose for at least 4 weeks prior to enrollment into study. PAH-specific agents can include: prostanoids, prostacyclin receptor agonist, endothelin receptor antagonists, phosphodiesterase-5 inhibitors and soluble guanylate cyclase stimulator agents alone or in combination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

ALPHA Trial Summary

This trial is testing whether or not using allogeneic CDCs (cellular therapy) can help reduce adverse remodeling in PAH, a progressive condition for which there is no cure.

Eligible Conditions
  • Pulmonary Arterial Hypertension

ALPHA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ALPHA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Safety (Early) endpoints including the determination of Gas Exchange and Hemodynamics; Detection of Arrhythmias; Sudden unexpected death and Mortality and Morbidity
Secondary outcome measures
Exploratory Secondary Efficacy Endpoints measuring right ventricular function and pressure estimates
Secondary Safety (Long Term) endpoints including ongoing monitoring of events listed for primary safety endpoints as well as long term monitoring for a composite of time to clinical worsening.

ALPHA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Biological: Allogeneic Human Cardiosphere-Derived Cells (CDCs)Experimental Treatment1 Intervention
The Phase 1a portion (N=6 subjects) consists of an open-label, single-arm, study design - dose escalation. The potentially conducted Phase 1b portion of the study (N=20 subjects) consists of a double-blind, randomized, placebo-controlled study design.
Group II: PlaceboPlacebo Group1 Intervention
The placebo study arm only applies to the Phase Ib portion of the study design. The Phase Ia portion (N=6 subjects) consists of an open-label, single-arm, study design. The potentially conducted Phase Ib portion of the study (N=20 subjects) consists of a double-blind, randomized, placebo-controlled study design with a 1:1 ratio.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Human Cardiosphere-Derived Stem Cells
2017
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
497 Previous Clinical Trials
164,455 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
62 Previous Clinical Trials
3,127 Total Patients Enrolled
Michael I Lewis, MDPrincipal InvestigatorCedars-Sinai Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall participant count for this experiment?

"At present, this medical trial is not registering patients. The study was published on October 1st 2017 and updated most recently on March 7th 2022. For those who are seeking alternative studies, there are currently 749 clinical trials related to pulmonary arterial hypertension that are accepting participants as well as 3 studies involving allogeneic human cardiosphere-derived stem cells actively recruiting individuals."

Answered by AI

Is this experiment currently seeking participants?

"Clinicaltrials.gov shows that this specific medical trial, initially posted on October 1st 2017 and last updated on March 7th 2022, is no longer looking for participants; however, there are currently 752 other trials actively recruiting patients."

Answered by AI

Is this clinical trial enrolling participants over the age of sixty?

"The set of requirements to take part in this clinical trial requires that the participant is between 18 and 75 years. It was observed that 56 trials were conducted on those younger than 18 while 665 studies were administered for seniors aged 65 or more."

Answered by AI

What potential risks exist with Allogeneic Human Cardiosphere-Derived Stem Cells?

"With minimal clinical evidence to support the safety and efficacy of Allogeneic Human Cardiosphere-Derived Stem Cells, this treatment was assigned a score of 1."

Answered by AI

Does my profile meet the requirements for participation in this research study?

"This clinical trial is enlisting 26 individuals aged between 18 and 75 with pulmonary arterial hypertension. To be eligible, patients must have an oxygen saturation level of 90% or above at rest (either independent of supplemental O2 or not), a medically confirmed case of IPAH, HPAH, PAH-CTD, or PAH-HIYV being in either NYHA Functional Class II or III, 6MWD greater than 150m; they also need to have been on stable doses of certain pulmonary medications for four weeks prior to enrollment. Additionally all those with HIV need to be taking effective HAART regimens and the PC"

Answered by AI

Have any prior experiments utilized Allogeneic Human Cardiosphere-Derived Stem Cells?

"Currently, there are three active research studies examining Allogeneic Human Cardiosphere-Derived Stem Cells with one study in its third phase. Multiple medical sites across 14 cities - such as Los Angeles, California - are conducting these investigations into this therapeutic treatment option."

Answered by AI
~4 spots leftby Mar 2025