COBLT Study SOP Amendment Summary

COBLT STUDY SOP AMENDMENT #5 (December 2000)

Substantive changes to the SOP are detailed below:

Chapter 1 - Background and Cord Blood Bank Organization

In Section 1.1, the summary has been revised to reflect changes in the transplant study purpose.
In Section 1.2, the organization of the cord blood banks has been revised to reflect the current number of cord blood banks and transplant centers.

Chapter 4 - Processing Procedures

In Section 4.5, a quality control measure addressing the release of CBUs from long term storage when more than one unit is released at a time has been added.

Chapter 5 - Shipping Procedures

In Section 5.1, the acceptable temperature range for temporarily storing CBUs has been revised to 15⁰ to 25⁰ C

Chapter 6 - Sample Testing and Characterization

In Section 6.2, restricting collections to mothers < 36 years has been removed, the procedure for obtaining samples for genetic screening has been clarified, and the laboratory designations for enzyme testing have been removed.
In Section 6.5, the flow cytometry procedures have been revised to replace TriTest stains with MultiTest stains for tubes 7 and 8 and allow the CD34+ subset analysis to be optional.

Chapter 7 - Process Improvement Policy

In Section 7.2, the requirement to submit pre- and post-thaw data on one CBU to the MCC every month has been revised to pre- and post-thaw data on one cord blood unit every three months.

Chapter 8 - Data Collection

In Section 8.1, details of locking CBU data records have been added.
In Section 8.2.3, the exclusion criteria for the Donor and Delivery Information Form have been revised to allow CBUs collected from mothers >35 years of age with no documentation of amniocentesis or chorion villous sampling tests to be eligible for banking.
In Section 8.2.5, a question on the number of collection bags used has been added to the CBU Collection and Receipt Form (V04, 10/99).
In Section 8.2.6, the processing bag manufacture date was modified to the manufactures expiration date on the CBU Processing Form (V03, 12/99) to reflect changes in the bag set packaging information.
In Section 8.2.8 , the Graft Characterization Form (V06, 12/99) has been revised to capture data from MultiTest stains.
In Section 8.2.9, on the CBU Exclusion and Quarantine Release Form (V03, 12/00), mother's age has been removed from the criteria for an unsatisfactory amniocentesis or chorion villous sampling or FISH test.

Appendix F - Investigators Brochure

The Transplant Center Feedback Sheet has been updated to include collection weight, infant gender, and recipient conditioning regimen.
The CBU Thawing Procedure has been revised to include additional information on thawing techniques, clarification on the filter pore size for handling clumps in the final product, and a procedure note on performing cell viability using Trypan Blue.
The Procedure for Infusing Thawed CBU has been revised to replace reinfusion with infusion.
The Product Information has been revised to include current information on cord blood transplantation.