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Immune Disorder HSCT Protocol

RECRUITINGPhase 2Sponsored by Washington University School of Medicine
Actively Recruiting
PhasePhase 2
SponsorWashington University School of Medicine
Started2013-03
Est. completion2027-03
Eligibility
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT01821781

Summary

This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders. A regimen that maximizes host immune suppression is expected to reduce graft rejection and optimize donor cell engraftment.

Eligibility

Healthy volunteers accepted
Inclusion Criteria:

* \</= 28 years of age
* Performance status \>/= 40
* DLCO \>/= 40%
* LVEF \>/=40% or LVSF \>/=26%
* Serum creatinine \< 2x ULN
* Liver enzymes \</= 5x ULN
* Negative pregnancy test
* Suitably matched donor (6/6 matched sib UCB, 8/8 matched sib BM or PBSC, 5-6/6 matched unrelated UCB, 7-8/8 matched unrelated BM, double cord)

Exclusion Criteria:

* Known diagnosis of HIV I/II
* Pregnant or breastfeeding
* Uncontrolled invasive fungal or bacterial infections within 1 month prior to starting alemtuzumab
* Uncontrolled viral infection within 1 week prior to starting alemtuzumab

Conditions15

Autoimmune Lymphoproliferative SyndromeChediak-Higashi SyndromeChronic Granulomatous DiseaseCommon Variable Immune DeficiencyDiGeorge SyndromeHeart DiseaseHemophagocytic LymphohistiocytosisHyper-IgMIPEXImmune Deficiency Disorders

Locations1 site

Washington University
St Louis, Missouri, 63110
Jeffrey Bednarski, MD314-454-6018Bednarski_J@kids.wustl.edu

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