Successful Use of Cryopreservation and Shipping of CD34-Selected Mismatched Related Donor Grafts for Treatment of Children

Background: T cell-depletion of haploidentical donor peripheral blood stem cell (PBSC) products is an important modality that may expand the donor pool for transplantation in pediatric patients. A survey of pediatric-center directors shows that many pediatric centers do not have an on-site stem cell processing laboratory (30%), and many laboratories do not perform graft manipulation. The successful use of cryopreserved grafts from centrally-processed PBSC collections could expand the availability of this modality to pediatric centers without on-site stem cell processing available.

Methods: Between 2009-2014, PBSCs were collected from 38 mismatched family member donors at Levine Children’s Hospital, Charlotte, NC. Seventy PBSC apheresis procedures were performed on-site for the 38 donor collections. PBSC products were shipped on frozen gel packs to University of California (UCSF) Stem Cell Processing Laboratory, per program SOP and FACT guidelines. Validated thermal shipping containers, with FACT compliant shipping labels, and door-to-door delivery were used. Total costs included an average $257 to ship each product. The product was inspected and stored at 4°C with next day processing. Processing with the CD34+ selection by CliniMACS® device took one day; products were immediately cryopreserved, then returned on the day of transplant in a liquid nitrogen dry shipper.

Results: PBSC products were collected for 36 patients. Median donor age was 29 years (range 12-52). Median number of apheresis collections was two (range 1-3). 34/36 patients received a CD34+selected cryopreserved product for 21 malignant and 15 non-malignant diseases. One patient died prior to transplant and one elected transplant elsewhere with a different donor. Pre-processing viability was above 98% on all products. Median post-processing viability was 96% (range 84-99%). Median cell dose infused was 21x10⁶CD34+/kg (range 8-24). There were no adverse events with infusion. Engraftment (ANC>500) occurred in 33/34 patients, with median engraftment day of 14 days (range 9-19). One primary graft failure occurred in a leaky-SCID patient, one secondary graft failure occurred, and both patients engrafted after a second T cell-depleted mismatched donor transplant. Shipping costs of PBSC in a dry shipper increased, from a median $622 in 2009 to $922 in 2014.

Conclusions: An off-site stem cell processing laboratory was used for CD34+ selection with the CliniMACS® device. The grafts were cryopreserved and shipped for transplant. The manipulated PBSC grafts from mismatched related family members were used for successful transplantation with prompt engraftment and relatively low associated transportation costs. This experience may improve accessibility to graft manipulated products for pediatric programs without an on-site stem cell processing laboratory.

Disclosures:

Nothing To Disclose

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