NCT04522986: COVID-19

An Exploratory Study of ADR-001 in Patients with Severe Pneumonia Caused by SARS-CoV-2 Infection

Completed Phase 1 Last updated 9 December 2024

What this trial tests

Phase 1 trial testing Mesenchymal stem cell in Severe Acute Respiratory Syndrome Coronavirus 2 in 6 participants. Completed in 2 February 2021.

Timeline

21 August 2020

Primary endpoint
2 February 2021

2 February 2021

Quick facts

Lead sponsor	Rohto Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	21 August 2020
Primary completion	2 February 2021
Estimated completion	2 February 2021
Sites	1 location across Japan

Drugs / interventions tested

• Mesenchymal stem cell

Conditions studied

• Severe Acute Respiratory Syndrome Coronavirus 2 — all drugs for Severe Acute Respiratory Syndrome Coronavirus 2 →

Sponsor

Rohto Pharmaceutical Co., Ltd. — full company profile →

Who can join

20 and older, any sex, with Severe Acute Respiratory Syndrome Coronavirus 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunomodulatory Mechanisms of Mesenchymal Stem Cells and Their Potential Clinical Applications.
   Huang Y, Wu Q, Tam PKH. · · 2022 · cited 143× · PMID 36077421 · DOI 10.3390/ijms231710023
2. Mesenchymal stem cells and their derived exosomes to combat Covid-19.
   Yousefi Dehbidi M, Goodarzi N, Azhdari MH, Doroudian M. · · 2022 · cited 41× · PMID 34363275 · DOI 10.1002/rmv.2281
3. Mesenchymal stem cell-based therapy and exosomes in COVID-19: current trends and prospects.
   Abdelgawad M, Bakry NS, Farghali AA, Abdel-Latif A, et al · · 2021 · cited 33× · PMID 34419143 · DOI 10.1186/s13287-021-02542-z
4. Mesenchymal stem cell-based treatments for COVID-19: status and future perspectives for clinical applications.
   Chen L, Qu J, Kalyani FS, Zhang Q, et al · · 2022 · cited 31× · PMID 35187617 · DOI 10.1007/s00018-021-04096-y
5. The Role of MSC Therapy in Attenuating the Damaging Effects of the Cytokine Storm Induced by COVID-19 on the Heart and Cardiovascular System.
   Ellison-Hughes GM, Colley L, O'Brien KA, Roberts KA, et al · · 2020 · cited 29× · PMID 33363221 · DOI 10.3389/fcvm.2020.602183
6. Mesenchymal stromal/stem cells (MSCs) and MSC-derived extracellular vesicles in COVID-19-induced ARDS: Mechanisms of action, research progress, challenges, and opportunities.
   Moradinasab S, Pourbagheri-Sigaroodi A, Zafari P, Ghaffari SH, et al · · 2021 · cited 27× · PMID 33932694 · DOI 10.1016/j.intimp.2021.107694
7. Clinical applications of mesenchymal stromal cell-based therapies for pulmonary diseases: An Update and Concise Review.
   Chen X, Wang F, Huang Z, Wu Y, et al · · 2021 · cited 23× · PMID 34220313 · DOI 10.7150/ijms.59218
8. An update to "novel therapeutic approaches for treatment of COVID-19".
   Hossein-Khannazer N, Shokoohian B, Shpichka A, Aghdaei HA, et al · · 2021 · cited 21× · PMID 33392632 · DOI 10.1007/s00109-020-02027-1