Table 4 List of clinical trials for the provision of OOS products in Japan
No | Common name | Overview of the study | Target patients | Source |
|---|---|---|---|---|
1 | Human (autologous) skeletal muscle-derived cell sheet | A multicentre exploratory study on the quality of Heart Sheet among patients who met the selection criteria | Patients with severe heart failure due to chronic ischaemic heart disease | UMIN000029824 |
2 | Tisagenlecleucel | Part 1 will evaluate the safety and efficacy of tisagenlecleucel in the target patients, consistent with the regulatory approved indications listed in the tisagenlecleucel prescribing information in each country/region. Part 2 will evaluate the safety and efficacy of tisagenlecleucel in patients with relapsed/refractory (r/r) acute lymphoblastic leukaemia (ALL) and r/r non-Hodgkin lymphoma (NHL) | Indications for use in the prescribing information: (Part 1: paediatric/young adult patients with r/r B-cell ALL and adult patients with r/r large B-cell lymphoma (including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma); Part 2: patients with r/r ALL and r/r NHL | jRCT1080224903 |
3 | Human (autologous) bone marrow-derived mesenchymal stem cells | The purpose of this study is to administer OOS Stemirac Injection as a compassionate treatment to patients with traumatic spinal cord injury who are unable to receive Stemirac Injection because it does not meet some of the in-process control specifications and shipping specifications, and to obtain efficacy and safety data | Patients with traumatic spinal cord injury | jRCT2013210056 |
4 | Axicabtagene ciloleucel | The clinical trial aims to allow patients who are scheduled to be treated with axicabtagene ciloleucel to be administered the OOS product on compassionate grounds if the product they are receiving does not meet the specifications | Patients who meet the requirements of the package insert (diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, high-grade B-cell lymphoma) | jRCT2013210008 |
To access the OOS product and evaluate its safety in adult individuals with a diagnosis of an approved indication listed in the package insert | Patients who meet the requirement of the package insert (relapsed or refractory large B-cell lymphoma) | jRCT2033230370 | ||
5 | Lisocabtagene maraleucel | To assess the safety of OOS products | Patients who meet the requirement of the package insert (relapsed or refractory large B-cell lymphoma) | jRCT2053200162 |
6 | Idecabtagene vicleucel | To evaluate the safety of OOS products | Patients who meet the requirement of the package insert (adult subjects with relapsed or refractory multiple myeloma) | jRCT2053220006 |