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Phase I trial outcome of amnion cell therapy in patients with ischemic stroke (I-ACT).
Phan, Thanh G; Lim, Rebecca; Chan, Siow T; McDonald, Hannah; Gan, Poh-Yi; Zhang, Shenpeng R; Barreto Arce, Liz J; Vuong, Jason; Thirugnanachandran, Tharani; Clissold, Benjamin; Ly, John; Singhal, Shaloo; Hervet, Marie Veronic; Kim, Hyun Ah; Drummond, Grant R; Wallace, Euan M; Ma, Henry; Sobey, Christopher G.
Afiliación
  • Phan TG; Clinical Trials, Imaging and Informatics Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
  • Lim R; Department of Neurology, Monash Health, Clayton, VIC, Australia.
  • Chan ST; The Ritchie Centre, Hudson Institute of Medical Research, Clayton, VIC, Australia.
  • McDonald H; Department of Obstetrics and Gynaecology, Monash University, Clayton, VIC, Australia.
  • Gan PY; The Ritchie Centre, Hudson Institute of Medical Research, Clayton, VIC, Australia.
  • Zhang SR; Department of Obstetrics and Gynaecology, Monash University, Clayton, VIC, Australia.
  • Barreto Arce LJ; The Ritchie Centre, Hudson Institute of Medical Research, Clayton, VIC, Australia.
  • Vuong J; Department of Obstetrics and Gynaecology, Monash University, Clayton, VIC, Australia.
  • Thirugnanachandran T; Department of Medicine, Centre for Inflammatory Diseases, Monash Medical Centre, School of Clinical Sciences, Monash University, Clayton, VIC, Australia.
  • Clissold B; Department of Immunology, Monash Health, Monash Medical Centre, Clayton, VIC, Australia.
  • Ly J; Department of Microbiology, Anatomy, Physiology and Pharmacology, Centre for Cardiovascular Biology and Disease Research, School of Agriculture, Biomedicine and Environment, La Trobe University, Bundoora, VIC, Australia.
  • Singhal S; Department of Microbiology, Anatomy, Physiology and Pharmacology, Centre for Cardiovascular Biology and Disease Research, School of Agriculture, Biomedicine and Environment, La Trobe University, Bundoora, VIC, Australia.
  • Hervet MV; Clinical Trials, Imaging and Informatics Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
  • Kim HA; Department of Neurology, Monash Health, Clayton, VIC, Australia.
  • Drummond GR; Clinical Trials, Imaging and Informatics Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
  • Wallace EM; Department of Neurology, Monash Health, Clayton, VIC, Australia.
  • Ma H; Clinical Trials, Imaging and Informatics Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
  • Sobey CG; Department of Neurology, Monash Health, Clayton, VIC, Australia.
Front Neurosci ; 17: 1153231, 2023.
Article en En | MEDLINE | ID: mdl-37229431
Background: We proposed a Phase I dose escalation trial to assess the safety of allogeneic human amniotic epithelial cells (hAECs) in stroke patients with a view to informing the design for a Phase II trial. Methods: The design is based on 3 + 3 dose escalation design with additional components for measuring MR signal of efficacy as well as the effect of hAECs (2-8 × 106/kg, i.v.) on preventing immunosuppression after stroke. Results: Eight patients (six males) were recruited within 24 h of ischemic stroke onset and were infused with hAECs. We were able to increase the dose of hAECs to 8 × 106 cells/kg (2 × 106/kg, n = 3; 4 × 106/kg, n = 3; 8 × 106/kg, n = 2). The mean age is 68.0 ± 10.9 (mean ± SD). The frequencies of hypertension and hyperlipidemia were 87.5%, diabetes was 37.5%, atrial fibrillation was 50%, ischemic heart disease was 37.5% and ever-smoker was 25%. Overall, baseline NIHSS was 7.5 ± 3.1, 7.8 ± 7.2 at 24 h, and 4.9 ± 5.4 at 1 week (n = 8). The modified Rankin scale at 90 days was 2.1 ± 1.2. Supplemental oxygen was given in five patients during hAEC infusion. Using pre-defined criteria, two serious adverse events occurred. One patient developed recurrent stroke and another developed pulmonary embolism whilst in rehabilitation. For the last four patients, infusion of hAECs was split across separate infusions on subsequent days to reduce the risk for fluid overload. Conclusion: Our Phase I trial demonstrates that a maximal dose of 2 × 106/kg hAECs given intravenously each day over 2 days (a total of 4 × 106/kg) is safe and optimal for use in a Phase II trial. Clinical trial registration: ClinicalTrials.gov, identifier ACTRN12618000076279P.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Revista: Front Neurosci Año: 2023 Tipo del documento: Article País de afiliación: Australia

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Revista: Front Neurosci Año: 2023 Tipo del documento: Article País de afiliación: Australia
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