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CompletedNCT04522986COVID-19Updated Dec 9, 2024

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

A Phase 1 interventional study of Mesenchymal stem cell in Severe Acute Respiratory Syndrome Coronavirus 2, sponsored by Rohto Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by Rohto Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Patients with Severe Pneumonia caused by SARS-CoV-2 infection are enrolled to the study. Adipose-derived mesenchymal stem cells (AD-MSCs) are administered once a week, total four times intravenously. Safety and efficacy of AD-MSCs are evaluated for 12 weeks after first administer.

02

Conditions studied

  • Severe Acute Respiratory Syndrome Coronavirus 2
03

In context

Severe Acute Respiratory Syndrome

376 studies on the registry are indexed under Severe Acute Respiratory Syndrome; 15 are open to participants now.

This study's enrollment of 6 is below the median of 145 across 211 interventional studies indexed under Severe Acute Respiratory Syndrome.

Browse Severe Acute Respiratory Syndrome studies →

Lead sponsor

Rohto Pharmaceutical Co., Ltd. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • SARS-CoV-2 infection is confirmed on antigen test or PCR test
  • Pulmonary infiltrative shadow is confirmed on chest X-ray test
  • Mechanical ventilation is being utilized, or Acute Respiratory Failure whose PaO2 is not being achieved to 80 mmHg in spite of High-flow oxygen therapy

Exclusion criteria

Exclusion Criteria:

  • Continue treatment for Pneumonia before SARS-CoV-2 infection
  • SOFA score >= 15
  • Infection type on DIC diagnosis criteria >= 4
  • Deep Venous Thrombosis
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Mesenchymal stem cell

    4 times dose of Mesenchymal stem cell

    Biological: Mesenchymal stem cell

Interventions

  • BiologicalMesenchymal stem cell

    1\*10\^8 cells are administered once a week, total four times intravenously.

06

What researchers measure

Primary outcomes

  1. Safety: Adverse Event

    Adverse events which appear in subjects with ADR-001 treatment are evaluated.

    Time frame: 12 weeks

07

Study locations

1 site
  • Osaka University Hospital
    Suita, Osaka 565-0871, Japan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2020 to primary completion in Feb 2021, 5 months.

Of 18 phase 1 interventional studies under Severe Acute Respiratory Syndrome, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 15. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2020
First posted
Aug 21, 2020
StartActual
Aug 21, 2020
Primary completionActual
Feb 2, 2021
CompletionActual
Feb 2, 2021
Last update
Dec 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04522986
Lead sponsor
Rohto Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Aug 21, 2020
Start date
Aug 21, 2020
Primary completion
Feb 2, 2021
Completion
Feb 2, 2021
Last update
Dec 9, 2024

Study contacts

Yuji Fujino, MD
principal investigator · Osaka University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Mesenchymal Stem Cell

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Other studies from this sponsor

Rohto Pharmaceutical Co., Ltd.

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