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NCT03043742

Stem Cell Heart Injections During Laser Revascularization Surgery for Treatment of Chronic Ischemic Heart Disease

Completed Phase 1 Last updated 11 December 2020
What this trial tests

Phase 1 trial testing Bone Marrow Derived Autologous CD133+ Selected Cell Product in Chronic Ischemic Heart Disease in 8 participants. Completed in 12 November 2020.

Timeline
12 July 2016
Primary endpoint
12 November 2020
12 November 2020

Quick facts

Lead sponsorMichael Sekela
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment8
Start date12 July 2016
Primary completion12 November 2020
Estimated completion12 November 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Michael Sekela — full company profile →

Who can join

18 and older, any sex, with Chronic Ischemic Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Assess the safety and effectiveness of stem cell application with regard to improvement in regional myocardial function in patients receiving Trans-Myocardial Laser Revascularization (TMR) and stem cells.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Locoregional delivery of stem cell-based therapies.
    Ng NN, Thakor AS. · · 2020 · cited 24× · PMID 32522806 · DOI 10.1126/scitranslmed.aba4564

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