Treatment Use of the CliniMACS® CD34 TCR Alpha/Beta for Allogenic Transplant (Expanded Access Use)

Recipient Inclusion Criteria: * Age less than 22 years of age * No available genotypically matched related donor (sibling) * Availability of a suitable donor and graft source * Haploidentical related mobilized peripheral blood cells * 9/10 or 10/10 allele matched (HLA-A, -B, -C, -DRB1, -DQB1) volunteer unrelated donor mobilized peripheral blood cells Donor Inclusion Criteria: * Matching as described in the Recipient and Donor Suitability Criteria * Size and vascular access appropriate by center standard for peripheral blood stem cell (PBSC) collection. Donors with inadequate peripheral access will require placement of an apheresis catheter for collection. * Must meet appropriate screening/eligibility requirements: * Haploidentical matched family members: screened by center health screens and found to be eligible. * Unrelated donors: meet suitability criteria to donate PBSC * HIV negative * Not pregnant or lactating * Recipient must not have high-level donor specific anti-HLA antibodies according to institutional practices. * Must agree to donate PBSC * Must give informed consent Recipient Suitability: \- Adequate organ functioning as demonstrated by: * MUGA ≥ 50% or ECHO \>30% * 24-hour Creatinine Clearance or Glofil ≥ 50 ml/min or Serum Creatinine ≤2 times the upper limit of normal * DLCO \> 65% of predicted value. FEV1 \>65% of predicted * AST / ALT ≤ 2.5 and/or Bilirubin ≤ 1.5 times the upper limit of normal * Pregnancy test negative * HIV 1 /…