Cellular, Tissue and Gene Therapies Advisory Committee Meeting

March 30, 2007




Guidance for Industry:  Minimally manipulated, unrelated, allogeneic placental/umbilical cord blood intended for hematopoietic reconstitution in patients with hematological malignancies.

Draft Guidance.  FDA:  http://www.fda.gov/cber/gdlns/cordbld.pdf.


Cairo, MS., Wagner EL, et al: Characterization of banked umbilical cord blood hematopoietic progenitor cells and lymphocyte subsets and correlation with ethnicity, birth weight, sex and type of delivery: a Cord Blood Transplant (COBLT) Study report. Transfusion 45:856-866, 2005.


Gluckman, E, Rocha, V, et al: Outcome of cord-blood transplantation from related and unrelated donors. NEJM 334(6):373-381, 2007.


Goodwin, HS, Grunzinger, LM et al: Long term cryostorage of UC blood units: ability of the integral segment to confirm both identity and hematopoietic potential. Cytotheraphy 5(1):80-86, 2003.


Rodriquez, L, Garcia, J, Querol, S, Predictive utility of the attached segment in the quality control of a cord blood graft. Bio. of Blood and Marrow Transpl. 11:247-251, 2005.


Rubinstein, P, Carrier,  C, et al: Outcomes among 562 recipients of placental-blood transplants from unrelated donors. NEJM 339(22):1565-1577.


Rubinstein, P, Dobrila, L, et al: Processing and cryopreservation of placental/umbilical cord blood for unrelated bone marrow reconstitution. Proc. Natl. Acad. Sci. 92:10119-10122, 1995.


Solves, P, Planelles, D, et al: Utility of bag segment and cryovial samples for quality control and confirmatory HLA typing in umbilical cord blood banking. Clin. Lab. Haem. 26:413-418, 2004.


Wagner, JE, Barker, JN et al: Transplantation of unrelated donor umbilical cord blood in 102 patients with malignant and nonmalignant diseases: influence of CD34 cell dose and HLA disparity on treatment-related mortality and survival. Blood 100(5):1611-1618, 2002.