A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial
Observational · No treatment assigned · 2 sites · Anterogen Co., Ltd.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 9 participants are expected to take part.
- Start date: 2016-11-16.
- Main results expected around 2026-12-31 (estimate from the record).
- 2 study sites listed (1 marked recruiting) in South Korea.
Main thing being measured
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability (up to 36 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease |
| Lead sponsor | Anterogen Co., Ltd. |
| Enrollment | 9 (estimated) |
| Start date | 2016-11-16 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2017-06-12 |
| Last updated | 2023-08-25 |
| 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 |
Interventions
- ALLO-ASC-CD (Biological)
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 interv…
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Subjects who are injected with ALLO-ASC-CD in phase 1 clinical trial of ALLO-ASC-CD-101. 2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: 1\. Subjects who are considered not suitable for the study by the principal investigator.
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Severance Hospital | Seoul | South Korea | Completed |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.