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Article: Phase I-II clinical trial assessing safety and efficacy of umbilical cord blood mononuclear cell transplant therapy of chronic complete spinal cord injury

TitlePhase I-II clinical trial assessing safety and efficacy of umbilical cord blood mononuclear cell transplant therapy of chronic complete spinal cord injury
Authors
KeywordsCentral pattern generator
Lithium
Mononuclear cells
Spinal cord injury (SCI)
Umbilical cord blood
Issue Date2016
PublisherCognizant Communication Corp. The Journal's web site is located at https://www.cognizantcommunication.com/journal-titles/cell-transplantation
Citation
Cell Transplantation, 2016, v. 25 n. 11, p. 1925-1943 How to Cite?
AbstractUmbilical cord blood-derived mononuclear cell (UCB-MNC) transplants improve recovery in animal spinal cord injury (SCI) models. We transplanted UCB-MNCs into 28 patients with chronic complete SCI in Hong Kong (HK) and Kunming (KM). Stemcyte Inc. donated UCB-MNCs isolated from human leukocyte antigen (HLA ≥4:6)-matched UCB units. In HK, four patients received four 4-μl injections (1.6 million cells) into dorsal entry zones above and below the injury site, and another four received 8-μl injections (3.2 million cells). The eight patients were an average of 13 years after C5-T10 SCI. Magnetic resonance diffusion tensor imaging of five patients showed white matter gaps at the injury site before treatment. Two patients had fiber bundles growing across the injury site by 12 months, and the rest had narrower white matter gaps. Motor, walking index of SCI (WISCI), and spinal cord independence measure (SCIM) scores did not change. In KM, five groups of four patients received four 4-μl (1.6 million cells), 8-μl (3.2 million cells), 16-μl injections (6.4 million cells), 6.4 million cells plus 30 mg/kg methylprednisolone (MP), or 6.4 million cells plus MP and a 6-week course of oral lithium carbonate (750 mg/day). KM patients averaged 7 years after C3-T11 SCI and received 3–6 months of intensive locomotor training. Before surgery, only two patients walked 10 m with assistance and did not need assistance for bladder or bowel management before surgery. The rest could not walk or do their bladder and bowel management without assistance. At about a year (41–87 weeks), WISCI and SCIM scores improved: 15/20 patients walked 10 m (p = 0.001) and 12/20 did not need assistance for bladder management (p = 0.001) or bowel management (p = 0.002). Five patients converted from complete to incomplete (two sensory, three motor; p = 0.038) SCI. We conclude that UCB-MNC transplants and locomotor training improved WISCI and SCIM scores. We propose further clinical trials.
Persistent Identifierhttp://hdl.handle.net/10722/225806
ISSN
2017 Impact Factor: 2.885
2015 SCImago Journal Rankings: 1.161
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorZhu, H-
dc.contributor.authorPoon, W-
dc.contributor.authorLiu, Y-
dc.contributor.authorLeung, GKK-
dc.contributor.authorWong, YW-
dc.contributor.authorFeng, Y-
dc.contributor.authorNg, SCP-
dc.contributor.authorTsang, KS-
dc.contributor.authorSun, DTF-
dc.contributor.authorYeung, DK-
dc.contributor.authorShen, C-
dc.contributor.authorNiu, F-
dc.contributor.authorXu, Z-
dc.contributor.authorTan, P-
dc.contributor.authorTang, S-
dc.contributor.authorGao, H-
dc.contributor.authorCha, Y-
dc.contributor.authorSo, KF-
dc.contributor.authorFleischaker, R-
dc.contributor.authorSun, D-
dc.contributor.authorChen, J-
dc.contributor.authorLai, J-
dc.contributor.authorCheng, W-
dc.contributor.authorYoung, W-
dc.date.accessioned2016-05-20T08:11:06Z-
dc.date.available2016-05-20T08:11:06Z-
dc.date.issued2016-
dc.identifier.citationCell Transplantation, 2016, v. 25 n. 11, p. 1925-1943-
dc.identifier.issn0963-6897-
dc.identifier.urihttp://hdl.handle.net/10722/225806-
dc.description.abstractUmbilical cord blood-derived mononuclear cell (UCB-MNC) transplants improve recovery in animal spinal cord injury (SCI) models. We transplanted UCB-MNCs into 28 patients with chronic complete SCI in Hong Kong (HK) and Kunming (KM). Stemcyte Inc. donated UCB-MNCs isolated from human leukocyte antigen (HLA ≥4:6)-matched UCB units. In HK, four patients received four 4-μl injections (1.6 million cells) into dorsal entry zones above and below the injury site, and another four received 8-μl injections (3.2 million cells). The eight patients were an average of 13 years after C5-T10 SCI. Magnetic resonance diffusion tensor imaging of five patients showed white matter gaps at the injury site before treatment. Two patients had fiber bundles growing across the injury site by 12 months, and the rest had narrower white matter gaps. Motor, walking index of SCI (WISCI), and spinal cord independence measure (SCIM) scores did not change. In KM, five groups of four patients received four 4-μl (1.6 million cells), 8-μl (3.2 million cells), 16-μl injections (6.4 million cells), 6.4 million cells plus 30 mg/kg methylprednisolone (MP), or 6.4 million cells plus MP and a 6-week course of oral lithium carbonate (750 mg/day). KM patients averaged 7 years after C3-T11 SCI and received 3–6 months of intensive locomotor training. Before surgery, only two patients walked 10 m with assistance and did not need assistance for bladder or bowel management before surgery. The rest could not walk or do their bladder and bowel management without assistance. At about a year (41–87 weeks), WISCI and SCIM scores improved: 15/20 patients walked 10 m (p = 0.001) and 12/20 did not need assistance for bladder management (p = 0.001) or bowel management (p = 0.002). Five patients converted from complete to incomplete (two sensory, three motor; p = 0.038) SCI. We conclude that UCB-MNC transplants and locomotor training improved WISCI and SCIM scores. We propose further clinical trials.-
dc.languageeng-
dc.publisherCognizant Communication Corp. The Journal's web site is located at https://www.cognizantcommunication.com/journal-titles/cell-transplantation-
dc.relation.ispartofCell Transplantation-
dc.rightsCell Transplantation. Copyright © Cognizant Communication Corp.-
dc.subjectCentral pattern generator-
dc.subjectLithium-
dc.subjectMononuclear cells-
dc.subjectSpinal cord injury (SCI)-
dc.subjectUmbilical cord blood-
dc.titlePhase I-II clinical trial assessing safety and efficacy of umbilical cord blood mononuclear cell transplant therapy of chronic complete spinal cord injury-
dc.typeArticle-
dc.identifier.emailLeung, GKK: gkkleung@hku.hk-
dc.identifier.emailWong, YW: yatwa@hkucc.hku.hk-
dc.identifier.emailSo, KF: hrmaskf@hku.hk-
dc.identifier.authorityLeung, GKK=rp00522-
dc.identifier.authoritySo, KF=rp00329-
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.3727/096368916X691411-
dc.identifier.pmid27075659-
dc.identifier.scopuseid_2-s2.0-84994727966-
dc.identifier.hkuros257810-
dc.identifier.volume25-
dc.identifier.issue11-
dc.identifier.spage1925-
dc.identifier.epage1943-
dc.identifier.isiWOS:000387774300002-
dc.publisher.placeUnited States-

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