CrohnPhase 1ALLO-ASCNCT01440699
Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula
A Phase 1 study testing Allogenic human adipose-derived stem cells in people with Crohn, run by Anterogen Co., Ltd. at 3 sites in South Korea.
Trial summary
Adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Crohn
- What is being tested?
- Allogenic human adipose-derived stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Sep 2011to 8 Nov 2012
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with Crohn's disease
- Crohn's fistula which has been lasted at least for 3 months
- Negative for beta-HCG pregnancy test
Who cannot join
- Medical history with Variant Creutzfeldt Jacobs Disease
- Allergic to anesthetics or bovine protein or fibrin glue
- autoimmune disease other than Crohn's disease
- Infectious disease
- Sepsis or active tuberculosis
- pregnant or breast feeding woman
Show all 10Show fewer
- Inflammatory Bowel disease other than Crohn's disease
- active crohn's disease with CDAI score > 200
- malignant tumor
- fistula's diameter > 2 cm
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Keonghee Medical Center
Seoul
Seoul National University Hospital
Seoul
Yeonsei Medical Center
Seoul
About this study
Official title: Phase I Study of Dose Escalation of Human Allogenic Adipose-derived Stem Cells (ALLO-ASC) to Evaluate Safety and Efficacy in Patients With Crohn's Fistula
Adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.
Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in Phase I and II study on the patients with Crohn's fistula.
However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and efficacy in patients with Crohn's fistula.
- Conditions
- Crohn
- Being tested
- Allogenic human adipose-derived stem cells
- Keywords
- Crohn's fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogenic human adipose-derived stem cellsBiological
Also called ALLO-ASC
ALLO-ASC 1xE7 cells/mL is injected once along the fistula. If there is no safety issue for 4 weeks, 3 more people could be enrolled who are subject to ALLO-ASC 3xE7 cells/mL.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | For ALLO-ASC 1xE7 cells/ml,3 patients are to be enrolled. If there is no safety issue, 3 more patients will be enrolled to be treated with ALLO-ASC 3xE7 cells/ml. Receives: Biological: Allogenic human adipose-derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
General safety (Laboratory screening, adverse effects, immunological response, local tolerance)
Measured: Week8
Secondary outcomes (2)
Proportion of patients with sustained efficacy
Proportion of patients with more than 50% healed fistula at Month 8 Following up whether there is a recurrence at Month 8
Measured: Month 8
Proportion of patients with adverse effects
Evaluate the safety at 8 months whether any kind of AE occurs.
Measured: at month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startSep 2011
- Primary completion11 Oct 2012
- Study completion8 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CrohnStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TI Kim, MD, PhD, Principal investigator, Yeonsei Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440699
- Sponsor's protocol ID
- ALLO-ASC-101
- Acronym
- ALLO-ASC
- Status last verified
- Sep 2011
- First submitted
- 19 Sep 2011
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Dose Escalation of Human Allogenic Adipose-derived Stem Cells (ALLO-ASC) to Evaluate Safety and Efficacy in Patients With Crohn's Fistula
- ClinicalTrials.gov ID
- NCT01440699
- Acronym / sponsor ID
- ALLO-ASC / ALLO-ASC-101
- Conditions
- Crohn
- Keywords
- Crohn's fistula
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- 11 Oct 2012 (actual)
- Study completion
- 8 Nov 2012 (actual)
- First posted
- 26 Sep 2011 (estimated)
- 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.
Adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.
Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in Phase I and II study on the patients with Crohn's fistula.
However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and efficacy in patients with Crohn's fistula.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Allogenic human adipose-derived stem cellsFor ALLO-ASC 1xE7 cells/ml,3 patients are to be enrolled. If there is no safety issue, 3 more patients will be enrolled to be treated with ALLO-ASC 3xE7 cells/ml. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed with Crohn's disease
- Crohn's fistula which has been lasted at least for 3 months
- Negative for beta-HCG pregnancy test
Key exclusion criteria (10 listed)
- Medical history with Variant Creutzfeldt Jacobs Disease
- Allergic to anesthetics or bovine protein or fibrin glue
- autoimmune disease other than Crohn's disease
- Infectious disease
- Sepsis or active tuberculosis
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 |
|---|---|---|
| Allogenic human adipose-derived stem cellsAlso: ALLO-ASCALLO-ASC 1xE7 cells/mL is injected once along the fistula. If there is no safety issue for 4 weeks, 3 more people could be enrolled who are subject to ALLO-ASC 3xE7 cells/mL. | Biological | Treatment |
Primary outcome
General safety (Laboratory screening, adverse effects, immunological response, local tolerance)
Time frame: Week8
2 secondary outcomes
Proportion of patients with sustained efficacy
Time frame: Month 8
Proportion of patients with adverse effects
Time frame: at month 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
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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.
TI Kim, MD, PhD principal investigator
Yeonsei Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogenic human adipose-derived stem cells in people with Crohn, run by Anterogen Co., Ltd. at 3 sites in South Korea.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
General safety (Laboratory screening, adverse effects, immunological response, local tolerance) (time frame: Week8). 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 25 Aug 2023.