N/A N=150 Treatment

Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders

Hematologic Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03093844 ↗

Enrolled (actual)

150

Serious AEs

1.3%

Results posted

Aug 2025

Primary outcome: Primary: The Number of Patients With Successful Engraftment — 144 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Miltenyi CliniMACS® CD34 Reagent System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Nov 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Patients With Successful Engraftment	144	—

Summary

This is a study to evaluate the safety and efficacy of Miltenyi CliniMACS® CD34 Reagent System to promote engraftment of haploidentical CD34+ selected cells combined with single unit umbilical cord blood transplant for treatment of high-risk hematologic disorders.

Eligibility Criteria

Inclusion Criteria - Recipient

Ages 18-80 years inclusive
Diagnosed with high risk hematologic disorders warranting stem cell transplant per institutional standard of care
Lack HLA-identical related donor
Availability of at least one HLA- haploidentical (i.e. => 5/10 and <= 8/10 HLA match) related donor (HLA-A, B, C, DR, and DQ loci) who is available to donate CD34+ cells.
Availability of at least one 4/6 HLA-matched (HLA-A, B, and DR loci) cord blood unit from the National Marrow Donor Program (NMDP). The cord blood unit must contain a minimum TNC (prior to thawing) of at least 2x107 cells per kilogram of recipient body weight
Ability to comprehend the nature of the treatment 6.2. Exclusion Criteria - Recipient (any of the following)
HLA identical (6/6) related donor available and readily accessible at time of transplantation evaluation
Any patient not meeting institutional standard guidelines for transplant eligibility

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03093844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.