Ann: FDA Grants Rare Pediatric Disease Designation for Revascor, page-84

There's a reason not all phase 1 trials are automatic accelerated approvals.

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"Intramyocardially delivered Lomecel-B appears safe in HLHS patients and may favourably affect RV performance. Circulating exosomes of transplanted MSC [medicinal signalling cells, not stem cells] - specific provide novel insight into bioactivity. Conduct of a controlled phase trial is warranted and is underway"

To:
"In the HLHS trial a single intramyocardial administration of REVASCOR at the time of staged surgery resulted in significantly increased LV systolic and diastolic volumes over 12 months compared with control. These changes are indicative of clinically important growth of the small left ventricle that can help facilitate a subsequent surgical correction allowing for a normal two ventricle circulation. Improvement in left ventricular functional outcomes with REVASCOR may encourage more widespread use of surgical procedures to create a functioning left ventricle in children with HLHS resulting in reduction in long-term morbidity and mortality compared with other medical and/or surgical approaches."