A PHASE III TRIAL OF ALD-101 ADUVANT THERAPY of UNRELATED UMBILICAL CORD BLOOD TRANSPLANTATION (UCBT) IN PATIENTS WITH INBORN ERRORS OF METABOLISM - UCBT-002

Aldagen, Inc.0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Patients must have a confirmed diagnosis of inborn error of metabolism. Diagnosis to be confirmed by two appropriate tests (enzyme or mutation analysis) before study entry.
•Patients must be < 16 years of age at the time of study enrollment.
•Patients must be >= 5 kg in weight.
•Patients must have a good performance status (Lansky >= 80%).
•Patients must have adequate function of other organ systems.
•Patients must have a minimum life expectancy of at least 6 months.
•Patient must be determined to be a good candidate for a standard UCBT according to the investigator and standard eligibility work-up at the site.

•Patients that are HIV, Hepatitis B and/or Hepatitis C positive.
•Patients that are concurrently involved in any other clinical study that affects engraftment or immune reconstitution (e.g., other hematopoietic growth factors).
•Patients with uncontrolled infections.
•Patients with prior allogeneic stem cell transplant with cytoreduction preparative therapy within 12 months of enrollment.

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