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αβ+ T-cell depletion with Miltenyi CliniMACS system for Sickle Cell Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sickle Cell Diseaseαβ+ T-cell depletion with Miltenyi CliniMACS system - Device
Eligibility
2 - 25
All Sexes
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Study Summary

This trial will test whether a stem cell transplant can be a safe and effective treatment for sickle cell disease.

Eligible Conditions
  • Sickle Cell Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT)

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 1 year post transplant

1 year post transplant
Estimate 1-year overall and event-free survival after Hap-HSCT
Observe incidence of severe chronic GvHD as defined by grades III and IV
Observe the incidence of grades I through IV chronic GvHD
100 days post transplant
Observe incidence of severe acute GvHD as defined by grades III through IV
Observe the incidence of grades I through IV acute GvHD
100 days post-Hap-HSCT
Safety, as measured by incidence of graft failure, grade III/IV irreversible end organ toxicity, grade III/IV aGvHD, or death within 100 days post-Hap-HSCT

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
αβ-TCR/CD19 cell depleted haploidentical hematopoietic stem cell graft
1
T-allo10
2
TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT)

Trial Design

2 Treatment Groups

Stage I
1 of 2
Stage II
1 of 2

Experimental Treatment

38 Total Participants · 2 Treatment Groups

Primary Treatment: αβ+ T-cell depletion with Miltenyi CliniMACS system · No Placebo Group · N/A

Stage I
Device
Experimental Group · 1 Intervention: αβ+ T-cell depletion with Miltenyi CliniMACS system · Intervention Types: Device
Stage II
Device
Experimental Group · 1 Intervention: αβ+ T-cell depletion with Miltenyi CliniMACS system · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post transplant

Who is running the clinical trial?

University of ChicagoLead Sponsor
925 Previous Clinical Trials
753,294 Total Patients Enrolled
Michele Nassin, MDPrincipal InvestigatorUniversity of Chicago
John Cunningham, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
126 Total Patients Enrolled

Eligibility Criteria

Age 2 - 25 · All Participants · 5 Total Inclusion Criteria

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References

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