Stem CellsPhase 1ALFNCT03629015
Safety Study of Stemchymal® in Acute Liver Failure
A Phase 1 study testing Stemchymal® in people with Stem Cells and Adult Stem Cells, run by Steminent Biotherapeutics Inc. at 1 site in Taiwan.
Trial summary
To investigate the safety of Stemchymal® via intravenous (IV) infusion in acute liver failure (ALF) and acute on chronic liver failure (ACLF) patients. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Stem Cells, Adult Stem Cells, Acute Liver Failure
- What is being tested?
- Stemchymal®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2018to 18 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ALF or ACLF patients.
- Subjects are between 20 and 70 years of age.
- MELD scores meet 17 ≤ MELD ≤ 26.
- Subjects who had completed signing informed consent.
Who cannot join
- Subjects who had been enrolled in any other cell therapy within six months.
- Females with a positive pregnancy test result.
- Subjects have contraindication for liver transplantation.
- Subjects with psychiatric illnesses.
- Subjects who are diagnosed as active tuberculosis (TB).
- Subjects with immunological disorders (e.g. autoimmune hepatitis) or using immunosuppressive drugs (e.g. steroid for immunosuppression) within six months prior to screening visit.
- Subjects with unstable illnesses or contraindication for this clinical trial according to investigator's judgment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety Study of Stemchymal® (Allogeneic Adipose-Derived Mesenchymal Stem Cells) Treating on Acute Liver Failure - An Open-Label, Single-Center Phase I Trial
To investigate the safety of Stemchymal® via intravenous (IV) infusion in acute liver failure (ALF) and acute on chronic liver failure (ACLF) patients.
- Conditions
- Stem Cells, Adult Stem Cells, Acute Liver Failure, Acute-On-Chronic Liver Failure, Steminent
- Being tested
- Stemchymal®
- Medical subject headings
- Liver Failure, Acute, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stemchymal®Biological
ALF/ ACLF patients will receive Stemchymal® through intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Stemchymal® | Experimental | Biological: Stemchymal® ALF/ ACLF patients will receive low (0.5 x 10^6 cells/kg) or high (2 x 10^6 cells/kg) dose of Stemchymal® through intravenous infusion Receives: Biological: Stemchymal® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Oct 2018 (estimated)
- Primary completion18 May 2020
- Study completion18 May 2020
Why it stopped: Corporate strategic consideration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem CellsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steminent Biotherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629015
- Sponsor's protocol ID
- AA01
- Acronym
- ALF
- Status last verified
- Oct 2022
- First submitted
- 30 Jul 2018
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety Study of Stemchymal® (Allogeneic Adipose-Derived Mesenchymal Stem Cells) Treating on Acute Liver Failure - An Open-Label, Single-Center Phase I Trial
- ClinicalTrials.gov ID
- NCT03629015
- Acronym / sponsor ID
- ALF / AA01
- Conditions
- Stem Cells, Adult Stem Cells, Acute Liver Failure, Acute-On-Chronic Liver Failure, Steminent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Corporate strategic consideration
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Steminent Biotherapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety of Stemchymal® via intravenous (IV) infusion in acute liver failure (ALF) and acute on chronic liver failure (ACLF) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stemchymal® | Experimental | Biological: Stemchymal®Biological: Stemchymal® ALF/ ACLF patients will receive low (0.5 x 10^6 cells/kg) or high (2 x 10^6 cells/kg) dose of Stemchymal® through intravenous infusion |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ALF or ACLF patients.
- Subjects are between 20 and 70 years of age.
- MELD scores meet 17 ≤ MELD ≤ 26.
- Subjects who had completed signing informed consent.
Key exclusion criteria (7 listed)
- Subjects who had been enrolled in any other cell therapy within six months.
- Females with a positive pregnancy test result.
- Subjects have contraindication for liver transplantation.
- Subjects with psychiatric illnesses.
- Subjects who are diagnosed as active tuberculosis (TB).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stemchymal®ALF/ ACLF patients will receive Stemchymal® through intravenous infusion | Biological | Stemchymal® |
Primary outcome
The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR)
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stemchymal® in people with Stem Cells and Adult Stem Cells, run by Steminent Biotherapeutics Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.