Open Actively Recruiting

ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApy

About

Brief Summary

Pulmonary Arterial Hypertension or PAH is a progressive condition for which there is no cure. Even with substantial pharmacologic advances in the modern treatment era, survival still remains unacceptably poor, as reported in large PAH registries. Preclinical studies suggest that the administration of allogeneic CDCs have the potential to reduce adverse arteriolar remodeling in PAH which was the basis for the approved investigational new drug (IND). The use of CDCs as an adjunctive therapy in patients comprising 4 sub-groups of patients with PAH in which inflammation and immune dysfunction are key pathophysiologic drivers of PAH.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
75 Years

Inclusion Criteria:

  • Confirmed clinical diagnosis of IPAH, HPAH, PAH-CTD, PAH-HIV
  • NYHA Functional Class: II or III
  • 6MWD > 150 m
  • Able to maintain O2 saturation at rest ≥ 90% (with or without supplemental O2). O2 use during the course of the study is permitted.
  • 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
  • All patients with PAH-HIV must be on a stable and effective HAART combination regimen
  • Pulmonary capillary wedge pressure (PCWP) or LVEDP < 15 mm Hg
  • Age: 18 -75 years
  • Ability to provide informed consent and follow-up with protocol procedures

Exclusion Criteria:

  • Diagnosis of PAH other than IPAH, HPAH, PAH-CTD or PAH-HIV
  • Right atrial pressure > 20 mmHg as measured by right heart catheterization (RHC) on day of pre-infusion
  • History of clinically-significant coronary artery disease, including myocardial infarction, coronary stent placement or coronary artery bypass surgery within the previous 5 years, LV dysfunction
  • History or demonstration of significant ventricular tachy-arrhythmias or conduction abnormalities
  • Significant interstitial lung disease (on imaging and PFTs; FVC: < 60%;
  • Chronic thromboembolic pulmonary hypertension (CTEPH)
  • Estimated glomerular filtration rate (GFR) ≤ 50 mL/min
  • Active uncontrolled infection
  • Non-pulmonary vascular disease with life expectancy of < 3 years
  • Hypersensitivity to contrast agents
  • Active allergic reactions
  • History of previous stem cell therapy
  • Participation in an on-going protocol studying an experimental drug or device
  • Current alcohol or drug abuse because of anticipated difficulty in complying with protocol-related procedures
  • Pregnant/nursing women as well as men and women of child-bearing potential without use of active and highly reliable contraception
  • Known history of viral hepatitis
  • Abnormal liver function (transaminases > 3 times the upper reference range; total bilirubin > 2 times the upper reference range without a reversible, identifiable cause
  • Evidence of tumor on screening of chest/abdominal/pelvic (body) CT scan
  • History of malignancy within the last 5 years, except for resected skin basal cell or squamous cell carcinoma, treated cervical dysplasia or treated in-situ cervical cancer grade 1
  • Any prior organ transplant
  • Being actively listed for, or under active consideration for, an organ transplant of any kind, including lung transplantation
  • Known hypersensitivity to bovine products
  • Known hypersensitivity to dimethyl sulfoxide (DMSO)
  • Any condition or treatment which (in the opinion of investigator), places the patient at an unacceptable risk if enrolled
  • Patients with PAH-HIV will be excluded with any of the following clinical conditions:
    • CD4 T-cell count < 200 /mm3 within 90 days prior to screening
    • A detectable viral load within 90 days prior to screening
    • Active opportunistic infections within 90 days prior to screening
    • Changes in antiretroviral regimen within 90 days prior to screening
  • Significant anemia or a falling Hb would make patient ineligible. Platelet counts ≤ 100,000/mm3 and absolute neutrophil count < 1,500/mm3 excludes the patient
  • History of heparin induced thrombocytopenia (HIT) (unless current HIT Panel is negative) NOTE: Those eligible individuals who have had four or more previous gadolinium contrast scans will have a cardiac MRI without contrast

Join this Trial

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Study Stats
Protocol No.
17-001165
Category
Medicine-Va Wadsworth Medical Center
Contact
Shelley Shapiro
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03145298
For detailed technical eligibility, visit ClinicalTrials.gov.