Major criteria
Minor criteria
T ≥ 38.3 °C with no identifiable infectious etiology
Hepatic dysfunction with either total bilirubin ≥ 2 mg/dL or transaminase levels ≥ 2x ULN
Erythrodermatous rash involving > 25 % BSA and not attributable to a medication
Renal insufficiency (SCr ≥ 2x baselines)
Noncardiogenic pulmonary edema, manifested by diffuse pulmonary infiltrates consistent with the diagnosis of hypoxia
Weight gain ≥ 2.5 % of baseline body weight
Transient encephalopathy unexplained by other causes
a.
The diagnosis of ES is made when a patient develops all three major criteria or two major and at least one minor criterion within 96 h of engraftment .
6.
This syndrome is often self-limited, resolving with discontinuation of growth factors:
a.
In more severe cases with symptomatic pulmonary involvement, corticosteroids (1 mg/kg/day) have been shown to decrease mortality.
b.
Additionally, C1 esterase inhibitor concentrates have been shown to improve outcome in small studies .
14.4 Foundation for the Accreditation of Cellular Therapy Standards for Review of Engraftment
The major objective of Foundation for the Accreditation of Cellular Therapy (FACT) is to promote quality medical and laboratory practice in HSCT and other therapies using cellular products. FACT Standards were formed from laboratory standards developed by the International Society for Cellular Therapy (ISCT) and from the clinical and training guidelines developed by the American Society of Blood and Marrow Transplantation (ASBMT). Consensus in medical literature and contributions of experts in the cellular therapy field also led to the development of the standards:
1.
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FACT standards define engraftment as “the reconstitution of recipient hematopoiesis with blood cells and platelets from a donor”. The standards require:
a.
Policies and procedures to describe the review of time to engraftment by the collection facility, processing facility, and clinical transplant program following cellular therapy product administration.
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