The MEND (MEseNchymal coviD-19) Trial: A Pilot, Open Label, Randomised Controlled Clinical Trial to Investigate Early Efficacy of CYP-001 in Adults Admitted to Intensive Care with COVID-19 (Protocol Version 2.0 dated 30 April 2020) [2020] NSWCATGD 17

NSW Civil and Administrative Tribunal New South Wales Medium Neutral Citation: The MEND (MEseNchymal coviD-19) Trial: A Pilot, Open Label, Randomised Controlled Clinical Trial to Investigate Early Efficacy of CYP-001 in Adults Admitted to Intensive Care with COVID-19 (Protocol Version 2.0 dated 30 April 2020) [2020] NSWCATGD 17 Hearing dates: 15 May 2020 Date of orders: 15 May 2020 Decision date: 29 June 2020 Jurisdiction: Guardianship Division Before: M D Schyvens, Deputy President Dr M J Wroth, Senior Member J L Newman, General Member Decision: See Appendix A Catchwords: CLINICAL TRIAL – pilot trial – COVID-19 – pandemic – COVID-19 Acute Respiratory Distress Syndrome requiring intensive care – new medication – mesenchymal stem cells – whether clinical trial meets criteria in s 45AA of the Guardianship Act – safety and ethical considerations – whether it is in the best interests of patients that they take part in the clinical trial – no disease specific treatment available – clinical trial approved under s 45AA(1) of the Guardianship Act – whether consent to participation should be given by person responsible – whether information and consent forms sufficient – approval given under s 45AB(1)(a) of the Guardianship Act. Legislation Cited: Guardianship Act 1987 (NSW), ss 4, 4(a), 33(2), 34(1), 40, 40(2)-(3), 42-45, 45AA, 45AA(1)-(2), 45AA(4), 45AB, 45AB(1), 45AB(1)(a), 45AB(2); Pt 5, Divs 3-4 Cases Cited: Shehabi v Attorney General (NSW) [2016] NSWCATAP 137 Texts Cited: Nil Category: Principal judgment Parties: Professor Ian Seppelt (Applicant) Representation: Nil File Number(s): NCAT 2020/0014276 Publication restriction: Decisions of the Guardianship Division of the Civil and Administrative Tribunal have been anonymised to remove any information that may identify any person involved in the Tribunal's proceedings: Civil and Administrative Tribunal Act 2013 (NSW), s 65.