Crohn DiseaseNCT03183661
A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial
An observational study of Crohn Disease, run by Anterogen Co., Ltd. at 2 sites in South Korea.
Trial summary
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- ALLO-ASC-CD
- Type of treatment
- Injection or infusion
- How many people
- 9 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 16 Nov 2016to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject is enrolled who are injected ALLO-ASC-CD intravenous infusion in phase 1 clinical trial of ALLO-ASC-CD-101.
Who may be able to join
- Subjects who are injected with ALLO-ASC-CD in phase 1 clinical trial of ALLO-ASC-CD-101.
- Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.
Who cannot join
- 1. Subjects who are considered not suitable for the study by the principal investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jae Hee Cheon, Ph D contact
South Korea2 sites, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Joosung Kim, MD, Ph.D., jooskim@snu.ac.kr,
- Completed
Severance Hospital
Seoul, 03722
About this study
Official title: Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101)
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.
Read the detailed description
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.
ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease, such as crohn's disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease.
- Conditions
- Crohn Disease
- Being tested
- ALLO-ASC-CD
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLO-ASC-CDBiological
Also called Allogenic adipose-derived mesenchymal stem cell
ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease. This study is a follow-up study without intervention.
| Study group | Role | What they receive |
|---|---|---|
| ALLO-ASC-CD injection | Subjects with ALLO-ASC-CD injection in phase 1 clinical trial of ALLOASC-CD-101 Receives: Biological: ALLO-ASC-CD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Evaluation of AE
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start16 Nov 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Hee Cheon, Ph D, Principal investigator, Yonsei UniversityJoo Sung Kim, Ph D, Principal investigator, Seoul National University HospitalYoung Ho Kim, Ph D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183661
- Sponsor's protocol ID
- ALLO-ASC-CD-102
- Status last verified
- Aug 2023
- First submitted
- 8 Jun 2017
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
- Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101)
- ClinicalTrials.gov ID
- NCT03183661
- Acronym / sponsor ID
- ALLO-ASC-CD-102
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jun 2017 (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.
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.
Detailed description
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.
ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease, such as crohn's disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALLO-ASC-CD injection | – | Biological: ALLO-ASC-CDSubjects with ALLO-ASC-CD injection in phase 1 clinical trial of ALLOASC-CD-101 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject is enrolled who are injected ALLO-ASC-CD intravenous infusion in phase 1 clinical trial of ALLO-ASC-CD-101.
Key inclusion criteria (2 listed)
- Subjects who are injected with ALLO-ASC-CD in phase 1 clinical trial of ALLO-ASC-CD-101.
- Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.
Key exclusion criteria (1 listed)
- 1. Subjects who are considered not suitable for the study by the principal investigator.
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 |
|---|---|---|
| ALLO-ASC-CDAlso: Allogenic adipose-derived mesenchymal stem cellALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease. This study is a follow-up study without intervention. | Biological | ALLO-ASC-CD injection |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: up to 36 months
Evaluation of AE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jae Hee Cheon, Ph D contact
Jae Hee Cheon, Ph D principal investigator
Yonsei University
Joo Sung Kim, Ph D principal investigator
Seoul National University Hospital
Young Ho Kim, Ph D principal investigator
Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Anterogen Co., Ltd. at 2 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 2 inclusion and 1 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: looking for participants now, 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 2 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jae Hee Cheon, Ph D (GENIUSHEE@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: up to 36 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 25 Aug 2023.