A Trial to Assess Haploidentical T-depleted Stem Cell Transplantation in Patients With SCD

NCT04201210 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2024-05-13

No results posted yet for this study

Summary

HSCT is currently the only curative option for SCD but less than 20% of SCD patients have a MD donor available. So far, all curative approaches beyond a MSD HSCT at young age are non-satisfactory. With the lack of a suitable donor for the vast majority of patients, the major question of this trial is, if a haploidentical αß/CD19+ T-cell depleted HSCT can be a valid alternative to a MSD HSCT. The main challenge in non-malignant diseases is to offer a safe and GvHD-free HSCT without rejection.

Conditions

Interventions

OTHER

TCRα/β+ and CD19+ depleted haploidentical stem cell transplantation

Haploidentical 5+/10 HSCT from a relative, α/β T-depleted

OTHER

Matched sibling donor transplantation

10/10 HSCT - matched family donor

Sponsors & Collaborators

  • University of Regensburg

    lead OTHER

Principal Investigators

  • Selim Corbacioglu, MD · University Hospital of Regensburg

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2028-03-31
Completion
2030-03-31

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04201210 on ClinicalTrials.gov