MGTA-456 in Patients With Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
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|ClinicalTrials.gov Identifier: NCT03406962|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Inherited Metabolic Disorders (IMD)||Drug: MGTA-456||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of MGTA-456 in Patients With Inherited Metabolic Disorders (IMD) Undergoing Hematopoietic Stem Cell Transplantation (HSCT)|
|Actual Study Start Date :||February 9, 2018|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||April 2020|
MGTA-456 is an expanded umbilical cord blood product used during single umbilical cord blood transplantation.
Hematopoietic stem cell transplantation will be done with the cell therapy product MGTA-456.
Other Name: HSC835
- Incidence of engraftment [ Time Frame: 42 days ]Engraftment is defined as achieving an absolute neutrophil count (ANC) ≥0.5 × 10⁹/L for 3 consecutive days.
- Incidence of infusion toxicities [ Time Frame: 48 hours ]Incidence of MGTA-456-related adverse events (AEs) that limit MGTA-456 administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406962
|Contact: Magenta Clinical Trialsfirstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Paul J Orchard, MD 612-626-2313 email@example.com|
|Study Director:||Magenta Study Director||Magenta Therapeutics|