NL-OMON32439
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Aldagen, Inc.
- Enrollment
- 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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