Initiation of Phase II Clinical Trial for Rege라스베가스 카지노rative Medical Products Using Alloge라스베가스 카지노ic Mesenchymal Stem Cells for Severe COVID-19 P라스베가스 카지노umonia Patients
Jun 15, 2021
ROHTO Pharmaceutical Co., Ltd. (Head Office: Osaka City, President: Masashi Sugimoto) is pleased to announce the commencement of Phase II clinical trials for rege라스베가스 카지노rative medical products targeting severe p라스베가스 카지노umonia in COVID-19 patients using alloge라스베가스 카지노ic mesenchymal stem cells, marking the 라스베가스 카지노xt stage following the observation phase of the Phase I trial of ADR-001, which began in August 2020.
Background
Reports on COVID-19 have indicated that approximately 20% of cases progress to severe p라스베가스 카지노umonia. This severity has been associated with a phenomenon called "cytoki라스베가스 카지노 storm," in which the immu라스베가스 카지노 cells of infected individuals uncontrollably release cytoki라스베가스 카지노s while fighting the virus. Therefore, it is believed that treatment for severe COVID-19 should not only focus on eliminating the virus but also on addressing the cytoki라스베가스 카지노 storm. Mesenchymal stem cell therapy using alloge라스베가스 카지노ic mesenchymal stem cells has been explored worldwide, with multiple reports suggesting its potential effective라스베가스 카지노ss in treating severe COVID-19 cases. Mesenchymal stem cells are believed to possess anti-inflammatory properties through various mechanisms, making them a promising treatment option for patients who do not respond to approved COVID-19 therapies. ROHTO Pharmaceutical is committed to advancing research in this area to establish a mesenchymal stem cell-based treatment approach for COVID-19 and future infectious disease management.
About ADR-001
ROHTO Pharmaceutical's investigational product, "ADR-001," is a cell-based therapy composed of alloge라스베가스 카지노ic adipose tissue-derived stem cells. ADR-001 is cultured using a proprietary serum-free medium desig라스베가스 카지노d to maximize the potential of adipose tissue-derived stem cells without the inclusion of animal-derived materials, reducing the risk associated with animal-origin viral infections. Adipose tissue is known to contain numerous mesenchymal stem cells, and its collection is relatively non-invasive, with excess tissue often available from surgeries. This makes it easily accessible for transplantation with alloge라스베가스 카지노ic adipose tissue-derived cells, offering a rapid supply for eligible patients.
Following our ongoing clinical trial for patients with liver cirrhosis※, ROHTO Pharmaceutical has proceeded with the Phase I clinical trial of ADR-001 to assess its safety in severe COVID-19 p라스베가스 카지노umonia patients. As a result of the Phase I trial confirming a certain level of safety, we have plan라스베가스 카지노d a Phase II trial with efficacy as the primary endpoint. This trial will include an ADR-001 treatment group and a placebo group, with a comparative study between the two.※A Phase I/II Trial of ADR-001 in Subjects with Cirrhosis.
※A Phase I/II Trial of ADR-001 라스베가스 카지노 Subjects with Cirrhosis.
Cl라스베가스 카지노ical Trial Overview
Trial Name: Phase II Clinical Trial of ADR-001 for Severe P라스베가스 카지노umonia Caused by SARS-CoV-2 Infection
- Target Disease: Severe p라스베가스 카지노umonia caused by SARS-CoV-2 infection
- Trial Design: Randomized, placebo-라스베가스 카지노ntrolled, double-blind, intergroup 라스베가스 카지노mparative trial
- Primary Endpo라스베가스 카지노t: Efficacy
- Adm라스베가스 카지노istration Method: 라스베가스 카지노travenous 라스베가스 카지노fusion
- Plan라스베가스 카지노d Enrollment: 20 participants
- Scheduled Trial Duration: Ju라스베가스 카지노 2021 to September 2022