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GTP Scenario # 4

GTP Scenario # 4. September 17,2005. Scenario # 4. A patient undergoes 2 Autologous PBPC collections. Day 1 = 0.3 x 10 6 CD34 + cells/kg Day 2 = 4.8 x 10 6 CD34 + cells/kg The patient begins a marrow suppressive 3 day prep immediately after the Day 2 collection.

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GTP Scenario # 4

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  1. GTP Scenario # 4 September 17,2005

  2. Scenario # 4 • A patient undergoes 2 Autologous PBPC collections. • Day 1 = 0.3 x 106 CD34+ cells/kg • Day 2 = 4.8 x 106 CD34+ cells/kg • The patient begins a marrow suppressive 3 day prep immediately after the Day 2 collection. • On Day -1 of transplant, the sterility samples on the Day 2 Collection (post collection & pre-freeze) are positive for gram positive cocci. • Pt’s physician wants to infuse both Day 1 and Day 2 Collections and pre-med with antibiotics.

  3. What should be considered? • Does release of the Day 2 product meet the definition of “Urgent Medical Need” as defined in 21 CFR1271.3 (u)? • Is there no comparable HCT/P available? • Would the recipient suffer death or serious morbidity without the product?

  4. What should be considered? • Does release of this product meet the 21CFR1271 definition of Urgent Medical Need? No • Since this is an autologous product, Urgent Medical Need is not applicable. • From a 21CFR1271 point-of-view, Urgent Medical Need is only appropriate for use in a Donor Eligibility Determination.

  5. What else should be considered? • Type of product. 361 (GTP) • The samples which were contaminated. Post-collection and pre-freeze • The fact that the patient has started the preparative regimen. • The organism identified is a gram positive cocci on Day 2 of testing.

  6. What Documentation Is Required? • Notification of the recipient’s physician. • Recipient consent. • FDA Deviation: Contaminated HCT/P are FDA reportable.

  7. Variation # 1 • What if the collection was 3 weeks before infusion and the patient had not started the preparative regimen. Should the patient be remobilized for additional collections? • This should be evaluated based on the organism(s) identified and other risk factors.

  8. Variation # 2 • What if the culture-positive product were from the Day 1 collection? • Since the product from Day 2 contains an acceptable dose of CD34+ cells, the product from Day 1 does not need to be administered.

  9. Variation # 3 • If the product were collected under IND, what should the laboratory do? • Since the product is under IND, the laboratory should notify the IND Sponsor. • The IND Sponsor should notify the FDA.

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