Multicentre standardisation of a clinical grade procedure for the preparation of allogeneic platelet concentrates from umbilical cord blood.
BACKGROUND
In addition to a largely prevalent use for bleeding prophylaxis, platelet concentrates from adult blood have also been used for many years to prepare platelet gels for the repair of topical skin ulcers. Platelet gel can be obtained by activation of fresh, cryopreserved, autologous or allogeneic platelet concentrates with calcium gluconate, thrombin and/or batroxobin. The high content of tissue regenerative factors in cord blood platelets and the widespread availability of allogeneic cord blood units generously donated for haematopoietic transplant but unsuitable for this use solely because of low haematopoietic stem cell content prompted us to develop a national programme to standardise the production of allogeneic cryopreserved cord blood platelet concentrates (CBPC) suitable for later preparation of clinical-grade cord blood platelet gel.


METHODS
Cord blood units collected at public banks with total nucleated cell counts <1.5×10(9), platelet count >150×10(9)/L and volume >50 mL, underwent soft centrifugation within 48 hours of collection. Platelet-rich plasma was centrifuged at high speed to obtain a CBPC with target platelet concentration of 800-1,200×10(9)/L, which was cryopreserved, without cryoprotectant, below -40 °C.


RESULTS
During 14 months, 13 banks produced 1,080 CBPC with mean (± standard deviation) volume of 11.4±4.4 mL and platelet concentration of 1,003±229×10(9)/L. Total platelet count per CBPC was 11.3±4.9×10(9). Platelet recovery from cord blood was 47.7±17.8%. About one-third of cord blood units donated for haematopoietic transplant could meet the requirements for preparation of CBPC. The cost of preparation was € 160.92/CBPC. About 2 hours were needed for one technician to prepare four CBPC.


CONCLUSIONS
This study yielded valuable scientific and operational information regarding the development of clinical trials using allogeneic CBPC.
Blood Transfusion Centre, Foundation Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Paolo
P
Rebulla
Italian National Blood Centre, National Institute of Health, Rome, Italy.
Simonetta
S
Pupella
Puglia Cord Blood Bank, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
Michele
M
Santodirocco
Blood Transfusion Centre, Foundation Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Noemi
N
Greppi
Pescara Cord Blood Bank, UOSD Tissue and Biobank, Department of Haematology, Transfusion Medicine and Biotechnologies, Ospedale Civile dello Spirito Santo, Pescara, Italy.
Ida
I
Villanova
Emilia Romagna Cord Blood Bank, Immunohaematology and Transfusion Medicine, Policlinico S. Orsola-Malpighi, Bologna, Italy.
Marina
M
Buzzi
Organ and Tissue Transplant Unit, Foundation Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Nicola
N
De Fazio
Italian National Blood Centre, National Institute of Health, Rome, Italy.
Giuliano
G
Grazzini
D000328:Adult; D001792:Blood Platelets / Q000166:cytology*; D001793:Blood Preservation; D002498:Centrifugation; D015925:Cryopreservation; D005312:Fetal Blood / Q000166:cytology*; D006801:Humans; D010976:Platelet Count; D053657:Platelet-Rich Plasma / Q000166:cytology*