Don de cellules souches hématopoïétiques à partir d’un donneur mineur : cadre réglementaire, information, évaluation de l’aptitude au don et parcours (SFGM-TC).
Don; Donation; Greffe de cellules souches hématopoïétiques; Guidelines; Haematopoietic stem cell transplant; Mineur; Minors; Paediatrics; Recommandations; Hematology; Oncology; Cancer Research
Abstract :
[en] Haematopoietic stem cell collection from paediatric donors is a common and life-saving practice, as evidenced by the fact that there is a growing annual number of cases of transplants from minor donors among SFGM-TC centers over the last decade. Still, medical use of human tissue from a healthy and underage donor requires proper regulations and medical management. The guidelines below aim at underlining the importance of pondering the legal, medical and ethical aspects of using stem cells from healthy paediatric donors and stress out the importance of obtaining informed consent at the time of assessing HLA compatibility. Combined medical and psychological assessments are required before the donation, as well as one month later and one year later to ensure of the child's physical and mental wellbeing. Bone marrow harvest under general anaesthetics remains the preferred method of collection for children. Peripheral blood stem cell collection should only be considered for children who will not require a central venous access for collection. We aim at offering guidelines centered on the healthy child donating stem cells and his/her wellbeing, and these should be regularly reviewed as medical practices evolve.
Disciplines :
Hematology
Author, co-author :
LEJEUNE, Marie ; Centre Hospitalier Universitaire de Liège - CHU > > Service d'hématologie clinique
Menard, Bertille; Service d'hématologie pédiatrique, hôpital de la Timone Enfants, AP-HM, 264, rue Saint-Pierre, 13005 Marseille, France
Servais, Sophie ; Université de Liège - ULiège > Département des sciences cliniques
ANDRIANNE, Christelle ; Centre Hospitalier Universitaire de Liège - CHU > > Service d'hématologie clinique
Capelle, Lucie; Service d'hématologie pédiatrique, CHU de Lille, avenue Eugène-Avinée, 59000 Lille, France
De Maistre, Ségolène; Service d'hématologie pédiatrique, hôpital Robert-Debré, AP-HP, 48, boulevard Sérurier, 75019 Paris, France
Fabaron, Catherine; Service d'onco-hematologie pédiatrique, CHU Purpan Toulouse, 1, place du Dr Baylac, 31300 Toulouse, France
Cornier, Marie Flata; Service d'hémato-oncologie pédiatrique, hôpitaux universitaires de Genève, rue Willy-Donzé, 1203 Genève, Suisse
Goutagny, Marie-Pierre; Service d'hématologie pédiatrique, IHOPe, 1, place Joseph-Renaut, 69008 Lyon, France
Pereira, Maguy; Service d'hématologie, CHU de Liège, 1, avenue de l'Hôpital, 4000 Liège, Belgique
Tardy, Clea; Service de pharmacie, hôpital Robert-Debré, AP-HP, 48, boulevard Sérurier, 75019 Paris, France
Turquet, Eric; Service d'onco-hematologie pédiatrique, CHU de Rennes, Hôpital Sud, 16, boulevard de Bulgarie, 35200 Rennes, France
Benakli, Malek; Coordinateur national du groupe algérien de travail sur la Greffe de cellules souches hématopoïétiques (GATGCSH), Centre Pierre et Marie Curie, rue Tebessi Larbi, Sidi M'Hamed, 16000 Alger, Algérie
BAUDOUX, Etienne ; Centre Hospitalier Universitaire de Liège - CHU > > Thérapie cellulaire
Evard, Solène; Centre hospitalier universitaire de Rennes-Inserm, CIC-1414, centre d'investigation clinique de Rennes, 2, rue Henri-le-Guilloux, 35033 Rennes, France
Faucher, Catherine; Agence de la biomédecine, 1, avenue du stade de France, 93212 Saint-Denis La Plaine cedex, France
Herrero, Gwenaelle; Association de patients, rue de la Fontenette 23, 1227 Carouge,, Suisse
RESILIAM
Magro, Léonardo; LIRIC, Inserm U995, CHU de Lille, université de Lille, 59000 Lille, France
Geurten, Claire ; Université de Liège - ULiège > Département des sciences cliniques > Médecine générale
Don de cellules souches hématopoïétiques à partir d’un donneur mineur : cadre réglementaire, information, évaluation de l’aptitude au don et parcours (SFGM-TC).
Alternative titles :
[en] Haematopoietic stem cell donation from minor donor: Respecting laws, assessing fitness, delivering information and good care (SFGM-TC).
Bitan, M., van Walraven, S.M., Worel, N., Ball, L.M., Styczynski, J., Torrabadella, M., et al. Determination of eligibility in related pediatric hematopoietic cell donors: ethical and clinical considerations. recommendations from a working group of the worldwide network for blood and marrow transplantation association. Biol Blood Marrow Transplant 22:1 (2016), 96–103.
Halter, J., Kodera, Y., Ispizua, A.U., Greinix, H.T., Schmitz, N., Favre, G., et al. Severe events in donors after allogeneic hematopoietic stem cell donation. Haematologica 94:1 (2009), 94–101.
Pulsipher, M.A., Logan, B.R., Kiefer, D.M., Chitphakdithai, P., Riches, M.L., Rizzo, J.D., et al. Higher risks of toxicity and incomplete recovery in 13- to 17-year-old females after marrow donation: RDSAFE peds results. Biol Blood Marrow Transplant 25:5 (2019), 955–964.
Styczynski, J., Balduzzi, A., Gil, L., Labopin, M., Hamladji, R.M., Marktel, S., et al. Risk of complications during hematopoietic stem cell collection in pediatric sibling donors: a prospective European Group for Blood and Marrow Transplantation Pediatric Diseases Working Party study. Blood 119:12 (2012), 2935–2942.
Sevilla, J., González-Vicent, M., Lassaletta, A., Ramírez, M., Pérez-Martínez, A., Madero, L., et al. Peripheral blood progenitor cell collection adverse events for childhood allogeneic donors: variables related to the collection and safety profile. Br J Haematol 144:6 (2009), 909–916.
Rennert, W., Cormier, K., Sprott, S., The Donor – recipient weight ratio is a reliable marker for cell yield in hematopoietic stem cell donations. OBM Transplantation, 5(4), 2021, 156, 10.21926/obm.transplant.2104156.
Furey, A., Rastogi, S., Prince, R., Jin, Z., Smilow, E., Briamonte, C., et al. Bone marrow harvest in pediatric sibling donors: role of granulocyte colony-stimulating factor priming and CD34+ cell dose. Biol Blood Marrow Transplant 24:2 (2018), 324–329, 10.1016/j.bbmt.2017.10.031 [Epub 2017 Oct 23. PMID: 29074373].
Switzer, G.E., Bruce, J., Kiefer, D.M., Kobusingye, H., Drexler, R., Besser, R.M., et al. Health-related quality of life among pediatric hematopoietic stem cell donors. J Pediatr 178 (2016), 164–170.e1.
Pulsipher, M.A., Nagler, A., Iannone, R., Nelson, R.M., Weighing the risks of G-CSF administration, leukopheresis, and standard marrow harvest: ethical and safety considerations for normal pediatric hematopoietic cell donors. Pediatr Blood Cancer 46:4 (2006), 422–433.
Shaw, B.E., Confer, D.L., Hwang, W., Pulsipher, M.A., A review of the genetic and long-term effects of G-CSF injections in healthy donors: a reassuring lack of evidence for the development of haematological malignancies. Bone Marrow Transplant 50:3 (2015), 334–340.
Tipton, R., Yakoub-Agha, I., How we harmonize HSCT clinical practices among the SFGM-TC centers. Bull Cancer 103:11s (2016), S193–S197.
Protocol No. 14 to the Convention for the Protection of Human Rights and Fundamental Freedoms, amending the control system of the Convention (2004).
Recommendation CM/Rec(2020)6 of the Committee of Ministers to member States on establishing harmonised measures for the protection of haematopoietic progenitor cell donors, (2020).
Europe/EQDM Co. Guide to the quality and safety of tissues and cells for human application 2022. Available from: https://freepub.edqm.eu/.
FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (2022).
Evans, D.W., The American Academy of Pediatrics policy statement on organ donation. Pediatrics 126:2 (2010), e491–e492, 10.1542/peds.2010-1717B [author reply e492; PMID: 20679310].
Chan, T.K., Tipoe, G.L., The policy statement of the American academy of pediatrics – children as hematopoietic stem cell donors – a proposal of modifications for application in the UK. BMC Med Ethics 14:43 (2013), 14–43, 10.1186/1472-6939-14-43.
Agence Nationale de Sécurité du Médicaments et des Produits de Santé. Décision du 7 février 2020 définissant les règles de bonnes pratiques relatives au prélèvement de tissus et de cellules du corps humain sur une personne vivante ou décédée, en vue d'une utilisation thérapeutique (2020).
Agence Nationale de Sécurité du Médicaments et des Produits de Santé. Décision du 05/08/2022 modifiant la décision du 07/02/2020 définissant les règles de bonnes pratiques relatives au prélèvement de tissus et de cellules du corps humain sur une personne vivante ou décédée, en vue d'une utilisation thérapeutique (2022).
Chabannon C, Benakli M, Alexandrova K, Coze C, Dalle JH, Giraud C, Huynh P, Kanouni T, Kanold-Iastawiecka J, Lesieur I, Levavasseur A, Yakoub-Agha I, Baudoux E. Cytaphérèses pédiatriques : recommandations de la société francophone de greffe de moelle et de thérapie cellulaire (SFGM-TC), Bulletin du Cancer. doi: 10.1016/BULCAN.2023.12.008. (in press).
Polomeni, A., Tardieu, L., Ainaoui, M., Andrianne, C., Bancillon, N., Chapel, V., et al. Un support d'information pour les donneurs apparentés de cellules souches hématopoïétiques : recommandations de la Société francophone de greffe de moelle et de thérapie cellulaire (SFGM-TC). Bull Cancer 104:12 (2017), S71–S75.
Bruno, B., Thibert, J.-B., Bancillon, N., Desbos, A., Fawaz, A., Fournier, I., et al. Greffe de cellules-souches hématopoïétiques – Information et consentement des donneurs et des receveurs : recommandations de la Société francophone de greffe de moelle et de thérapie cellulaire (SFGM-TC). Bull Cancer 103 (2016), S198–S200.
Prise en charge des donneurs apparentés de CSH à court et long termes 2010 [Available from: https://www.sfgm-tc.com/harmonisation-des-pratiques/53-pregreffe/104-prise-en-charge-des-donneurs-apparentes-de-csh-a-court-et-long-termes.
Duong, H.K., Savani, B.N., Copelan, E., Devine, S., Costa, L.J., Wingard, J.R., et al. Peripheral blood progenitor cell mobilization for autologous and allogeneic hematopoietic cell transplantation: guidelines from the American Society for Blood and Marrow Transplantation. Biol Blood Marrow Transplant 20:9 (2014), 1262–1273.