Multicentre standardisation of a clinical grade procedure for the preparation of allogeneic platelet concentrates from umbilical cord blood

Paolo Rebulla, Simonetta Pupella, Michele Santodirocco, Noemi Greppi, Ida Villanova, M. Buzzi, Nicola De Fazio, Giuliano Grazzini, Marino Argiolas, Paola Bergamaschi, Maria Bianchi, Tiziana Bonfini, Daniela Bovo, Marina Buzzi, Mauro Carta, Pier Luigi Cocco, L. De Felice, Lazzaro Di Mauro, Giovanni Foti, Noemi Greppi & 25 others Mariacarla Iorio, Elisabetta Liberatore, Maurizio Marconi, Benedetta Mazzanti, L. Mazzucco, Mario Pagano, Pasqualepaolo Pagliaro, Vincenzo Poggi, Giulia Pucci, S. Pupella, Paolo Rebulla, Sara Rinalducci, Bina Romano, Riccardo Saccardi, L. Salvaneschi, Michele Santodirocco, Valentina Schiavo, M. Screnci, Serena Spartano, Angela Totaro, Patrizia Urciuoli, Stefania Vaglio, C. Velati, Ida Villanova, Lello Zolla

Research output: Contribution to journalArticle

Abstract

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. Materials and methods. Cord blood units collected at public banks with total nucleated cell counts 150×109/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 800-1,200×109/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±229×109/L. Total platelet count per CBPC was 11.3±4.9×109. 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. Discussion. This study yielded valuable scientific and operational information regarding the development of clinical trials using allogeneic CBPC.

Original languageEnglish
Pages (from-to)73-79
Number of pages7
JournalBlood Transfusion
Volume14
Issue number1
DOIs
Publication statusPublished - Jan 1 2016

Fingerprint

Fetal Blood
Blood Platelets
Gels
Batroxobin
Calcium Gluconate
Skin Ulcer
Transplants
Platelet-Rich Plasma
Thromboplastin
Hematopoietic Stem Cells
Platelet Count
Centrifugation
Thrombin

Keywords

  • Platelet concentrate
  • Platelet gel
  • Skin ulcers
  • Umbilical cord blood

ASJC Scopus subject areas

  • Hematology
  • Immunology and Allergy

Cite this

Multicentre standardisation of a clinical grade procedure for the preparation of allogeneic platelet concentrates from umbilical cord blood. / Rebulla, Paolo; Pupella, Simonetta; Santodirocco, Michele; Greppi, Noemi; Villanova, Ida; Buzzi, M.; De Fazio, Nicola; Grazzini, Giuliano; Argiolas, Marino; Bergamaschi, Paola; Bianchi, Maria; Bonfini, Tiziana; Bovo, Daniela; Buzzi, Marina; Carta, Mauro; Cocco, Pier Luigi; De Felice, L.; Di Mauro, Lazzaro; Foti, Giovanni; Greppi, Noemi; Iorio, Mariacarla; Liberatore, Elisabetta; Marconi, Maurizio; Mazzanti, Benedetta; Mazzucco, L.; Pagano, Mario; Pagliaro, Pasqualepaolo; Poggi, Vincenzo; Pucci, Giulia; Pupella, S.; Rebulla, Paolo; Rinalducci, Sara; Romano, Bina; Saccardi, Riccardo; Salvaneschi, L.; Santodirocco, Michele; Schiavo, Valentina; Screnci, M.; Spartano, Serena; Totaro, Angela; Urciuoli, Patrizia; Vaglio, Stefania; Velati, C.; Villanova, Ida; Zolla, Lello.

In: Blood Transfusion, Vol. 14, No. 1, 01.01.2016, p. 73-79.

Research output: Contribution to journalArticle

Rebulla, P, Pupella, S, Santodirocco, M, Greppi, N, Villanova, I, Buzzi, M, De Fazio, N, Grazzini, G, Argiolas, M, Bergamaschi, P, Bianchi, M, Bonfini, T, Bovo, D, Buzzi, M, Carta, M, Cocco, PL, De Felice, L, Di Mauro, L, Foti, G, Greppi, N, Iorio, M, Liberatore, E, Marconi, M, Mazzanti, B, Mazzucco, L, Pagano, M, Pagliaro, P, Poggi, V, Pucci, G, Pupella, S, Rebulla, P, Rinalducci, S, Romano, B, Saccardi, R, Salvaneschi, L, Santodirocco, M, Schiavo, V, Screnci, M, Spartano, S, Totaro, A, Urciuoli, P, Vaglio, S, Velati, C, Villanova, I & Zolla, L 2016, 'Multicentre standardisation of a clinical grade procedure for the preparation of allogeneic platelet concentrates from umbilical cord blood', Blood Transfusion, vol. 14, no. 1, pp. 73-79. https://doi.org/10.2450/2015.0122-15
Rebulla, Paolo ; Pupella, Simonetta ; Santodirocco, Michele ; Greppi, Noemi ; Villanova, Ida ; Buzzi, M. ; De Fazio, Nicola ; Grazzini, Giuliano ; Argiolas, Marino ; Bergamaschi, Paola ; Bianchi, Maria ; Bonfini, Tiziana ; Bovo, Daniela ; Buzzi, Marina ; Carta, Mauro ; Cocco, Pier Luigi ; De Felice, L. ; Di Mauro, Lazzaro ; Foti, Giovanni ; Greppi, Noemi ; Iorio, Mariacarla ; Liberatore, Elisabetta ; Marconi, Maurizio ; Mazzanti, Benedetta ; Mazzucco, L. ; Pagano, Mario ; Pagliaro, Pasqualepaolo ; Poggi, Vincenzo ; Pucci, Giulia ; Pupella, S. ; Rebulla, Paolo ; Rinalducci, Sara ; Romano, Bina ; Saccardi, Riccardo ; Salvaneschi, L. ; Santodirocco, Michele ; Schiavo, Valentina ; Screnci, M. ; Spartano, Serena ; Totaro, Angela ; Urciuoli, Patrizia ; Vaglio, Stefania ; Velati, C. ; Villanova, Ida ; Zolla, Lello. / Multicentre standardisation of a clinical grade procedure for the preparation of allogeneic platelet concentrates from umbilical cord blood. In: Blood Transfusion. 2016 ; Vol. 14, No. 1. pp. 73-79.
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AU - Rebulla, Paolo

AU - Pupella, Simonetta

AU - Santodirocco, Michele

AU - Greppi, Noemi

AU - Villanova, Ida

AU - Buzzi, M.

AU - De Fazio, Nicola

AU - Grazzini, Giuliano

AU - Argiolas, Marino

AU - Bergamaschi, Paola

AU - Bianchi, Maria

AU - Bonfini, Tiziana

AU - Bovo, Daniela

AU - Buzzi, Marina

AU - Carta, Mauro

AU - Cocco, Pier Luigi

AU - De Felice, L.

AU - Di Mauro, Lazzaro

AU - Foti, Giovanni

AU - Greppi, Noemi

AU - Iorio, Mariacarla

AU - Liberatore, Elisabetta

AU - Marconi, Maurizio

AU - Mazzanti, Benedetta

AU - Mazzucco, L.

AU - Pagano, Mario

AU - Pagliaro, Pasqualepaolo

AU - Poggi, Vincenzo

AU - Pucci, Giulia

AU - Pupella, S.

AU - Rebulla, Paolo

AU - Rinalducci, Sara

AU - Romano, Bina

AU - Saccardi, Riccardo

AU - Salvaneschi, L.

AU - Santodirocco, Michele

AU - Schiavo, Valentina

AU - Screnci, M.

AU - Spartano, Serena

AU - Totaro, Angela

AU - Urciuoli, Patrizia

AU - Vaglio, Stefania

AU - Velati, C.

AU - Villanova, Ida

AU - Zolla, Lello

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N2 - 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. Materials and methods. Cord blood units collected at public banks with total nucleated cell counts 150×109/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 800-1,200×109/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±229×109/L. Total platelet count per CBPC was 11.3±4.9×109. 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. Discussion. This study yielded valuable scientific and operational information regarding the development of clinical trials using allogeneic CBPC.

AB - 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. Materials and methods. Cord blood units collected at public banks with total nucleated cell counts 150×109/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 800-1,200×109/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±229×109/L. Total platelet count per CBPC was 11.3±4.9×109. 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. Discussion. This study yielded valuable scientific and operational information regarding the development of clinical trials using allogeneic CBPC.

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KW - Platelet gel

KW - Skin ulcers

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