Crohn's DiseasePhase 1NCT02580617
A Study to Evaluate the Safety of ALLO-ASC-CD for Treatment of Crohn's Disease
A Phase 1 study testing ALLO-ASC in people with Crohn's Disease, run by Anterogen Co., Ltd. at 1 site in South Korea.
Trial summary
This is a phase I study to evaluate the safety of ALLO-ASC-CD for the treatment of crohn' disease. ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- ALLO-ASC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Nov 2015to Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 to 65 years of age
- Subject who is diagnosed Crohn's disease by endoscopic or radiologic result during more than 6 months
- Subject who show intolerance or failure of conventional therapy (steroids, immunosuppressive and TNF-alpha inhibitor)
- Subject who is included CDAI 220-450 during screening period
- CRP>0.5mg/dL during screening period
- Subject who show affected sites by crohn's disease in either ileum and large intestine or both of them, including more than 1 nonanastomotic ulcers as a result of colonoscopy.
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- Subjects who satisfy those clinical examination value below during screening period.
- Hemoglobin ≥ 8.0g/dL B. WBC ≥ 3,000/μL C. Lymphocyte ≥ 500/μL D.100,000/μL ≤ Platelet ≤ 1,200,000/μL E. AST and ALT ≤ 3 x the upper limit of normal F. ALP ≤ 3 x the upper limit of normal G.Serum creatinine ≤ the upper limit of normal H.Serum albumin ≥ 2.0g/dL I.PT , aPTT≤ the upper limit of normal
- Negative for urine beta-HCG for women of childbearing age.
- Subject is able to give written informed consent prior to study start and to comply with the study requirements.
Who cannot join
- Subject with gastro-intestinal tract A. Crohn's disease which is invaded only proximal ileum. B. The evidence of an intra abdominal abscess during screening period. C. The evidence of an abscess around the anus during screening period. D. Conditions of subtotal colectomy or total colectomy. E. Short bowel syndrome. F. Subject who conduct elemental diet, tube feeding or parenteral nutrition within 3 weeks before enrollment.
- Subject who have ileostomy or colostomy. H Subject who have a bowel stricture of large intestine that may be significant by PI's decision during screening period.
- In case that the PI anticipates that patients need to get a surgical intestinal tract surgery caused by crohn's disease.
- Subject who have adenoma of large intestine K. Subject who have chronic inflammation-associated dysplasia.
- Subjects who have been received biological therapy within 60 days of enrollment..
- Subject with infectious disease A. Acute or chronic active HBV, HAV and HIV B. Active tuberculosis. C. IGRA (Interferon-Gamma Release Assay) positive D. All kinds of live vaccine inoculation except influenza vaccine within 4weeks before registration E. Pneumonia, pyelonephritis and Infection of Clostridium within 4weeks during screening visit.
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- F.Subject has history of bacteremia or other serious bacterial or fungal infection in past 3 months.
- Subject who has malignant tumor or which is not cured yet
- Subject has any serious disease, in the opinion of the Investigator, would interfere with the evaluation of the study.
- Subject who has history of blood clots and other pathological arterial thrombosis or venous thrombosis
- Subject who has a hypersensitive reaction to bovine-derived proteins
- Subject who is surgery or trauma within 6 weeks before registration
- Subject who is pregnant or breast-feeding.
- Subjects who are unwilling to use an "effective" method of contraception during the study
- Subject who is experienced stem cell therapy
- Subject who has been enrolled in another clinical study within 4weeks days of screening
- Subject who has history of alcohol or drug abuse.
- Subject who is not able to understand the objective of this study or to comply with the study requirements
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University College of Medicine
Seoul
Won Ho Kim, MD., Ph D, 82-2-2228-1951, kimwonho@yuhs.ac
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Crohn's Disease
This is a phase I study to evaluate the safety of ALLO-ASC-CD for the treatment of crohn' disease. ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells.
Read the detailed description
Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore, their immunomodulatory effects are significant for treating immune-related diseases, such as crohn's disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease.
- Conditions
- Crohn's Disease
- Being tested
- ALLO-ASC
- 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-ASCBiological
Also called ALLO-ASC-CD
Infusion for Crohn's disease
| Study group | Role | What they receive |
|---|---|---|
| ALLO-ASC | Experimental | Group 1: 5.0 x 10^7 cells Group 2: 7.5 x 10^7 cells Group 3: 10.0 x 10^7 cells Receives: Biological: ALLO-ASC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Clinically measured abnormality of laboratory tests and adverse events)
Clinically measured abnormality of laboratory tests and adverse events
Measured: up to 4 weeks
Secondary outcomes (2)
CDAI value
Change in the CDAI value
Measured: up to 4 weeks
The ratio of patients applicable to CDAI <150
The ratio of patients applicable to CDAI <150
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study start9 Nov 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Won Ho Kim, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580617
- Sponsor's protocol ID
- ALLO-ASC-CD-101
- Status last verified
- Aug 2023
- First submitted
- 15 Oct 2015
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
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
- A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Crohn's Disease
- ClinicalTrials.gov ID
- NCT02580617
- Acronym / sponsor ID
- ALLO-ASC-CD-101
- Conditions
- Crohn's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2015 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Oct 2015 (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.
This is a phase I study to evaluate the safety of ALLO-ASC-CD for the treatment of crohn' disease. ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells.
Detailed description
Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore, their immunomodulatory effects are significant for treating immune-related diseases, such as crohn's disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALLO-ASC | Experimental | Biological: ALLO-ASCGroup 1: 5.0 x 10^7 cells Group 2: 7.5 x 10^7 cells Group 3: 10.0 x 10^7 cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is 18 to 65 years of age
- Subject who is diagnosed Crohn's disease by endoscopic or radiologic result during more than 6 months
- Subject who show intolerance or failure of conventional therapy (steroids, immunosuppressive and TNF-alpha inhibitor)
- Subject who is included CDAI 220-450 during screening period
- CRP>0.5mg/dL during screening period
Key exclusion criteria (18 listed)
- Subject with gastro-intestinal tract A. Crohn's disease which is invaded only proximal ileum. B. The evidence of an intra abdominal abscess during screening period. C. The evidence of an abscess around the anus during screening period. D. Conditions of subtotal colectomy or total colectomy. E. Short bowel syndrome. F. Subject who conduct elemental diet, tube feeding or parenteral nutrition within 3 weeks before enrollment.
- Subjects who have been received biological therapy within 60 days of enrollment..
- Subject with infectious disease A. Acute or chronic active HBV, HAV and HIV B. Active tuberculosis. C. IGRA (Interferon-Gamma Release Assay) positive D. All kinds of live vaccine inoculation except influenza vaccine within 4weeks before registration E. Pneumonia, pyelonephritis and Infection of Clostridium within 4weeks during screening visit.
- F.Subject has history of bacteremia or other serious bacterial or fungal infection in past 3 months.
- Subject who has malignant tumor or which is not cured yet
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-ASCAlso: ALLO-ASC-CDInfusion for Crohn's disease | Biological | ALLO-ASC |
Primary outcome
Safety (Clinically measured abnormality of laboratory tests and adverse events)
Time frame: up to 4 weeks
Clinically measured abnormality of laboratory tests and adverse events
2 secondary outcomes
CDAI value
Time frame: up to 4 weeks
The ratio of patients applicable to CDAI <150
Time frame: Week 4
Results and safety
Results are not available in the source record.
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.
Won Ho Kim principal investigator
Yonsei University
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 ALLO-ASC in people with Crohn's Disease, run by Anterogen Co., Ltd. at 1 site 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 10 inclusion and 18 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: status not confirmed, 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Won Ho Kim, MD., PhD (82-2-2228-1951, kimwonho@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Clinically measured abnormality of laboratory tests and adverse events) (time frame: up to 4 weeks). 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.