Crohn's DiseaseNCT02926300
Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)
An observational study of Crohn's Disease, run by Kang Stem Biotech Co., Ltd. at 7 sites in South Korea.
Trial summary
The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients who has history of FURESTEM-CD injection at least once. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- stem cells
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Nov 2015to Nov 2021
- Phase
- Observational
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gender: Both Age Limits: 19years to 70years Healthy Volunteers?: No.
Who may be able to join
- patients who has history of FURESTEM-CD Inj. injection at least once.
- patients who understand and voluntarily sign an informed consent form.
Who cannot join
- any other condition which the Principle Investigator judges would make subject unsuitable for study participation.
Trial locations and contacts
7 sites in 1 country.
Eun-ji Kang contact
7 sites in 1 country
South Korea7 sites, 7 recruiting
- Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
Tae-oh Kim
- Recruiting
Yeungnam University Medical Center
Daegu, 42415
Byung-Ik Jang
- Recruiting
Seoul National Universtiy Bundang Hospital
Seongnam-si, 13620
Hyuk Yoon
Hyuk Yoon
- Recruiting
Severance Hospital
Seoul, 03722
Jae-hee Cheon
- Recruiting
Asan Medical Center
Seoul, 138-736
Su-jung Kim
Ji-young Park
- Recruiting
Soeul National University Hospital
Soeul, 110-7441
Jong-pil Im
Jong-pil Im
- Recruiting
The Catholic University of Korea, St. Vincent'S Hospital.
Suwon, 16247
Kang-moon Lee
About this study
Official title: Extension Study, An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trials to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease
The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients who has history of FURESTEM-CD injection at least once.
Read the detailed description
This study is an extended study of KSTHD_FURESTEM-CD phase 1 / 2a clinical trials in patients with moderate active Crohn's disease who had received at least once a FURESTEM-CD injection. The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients for approximately 36 months (144 weeks).
- Conditions
- Crohn's Disease
- Being tested
- stem cells
- Keywords
- crohn's disease, stem cell therapy, inflammatory bowel disease, hUCB-MSC, UCB-MSC, Umbilical cord Blood, Rheumatoid Arthritis, RA, Stem cell, Cell therapy, Furestem, Mesenchymal stem cell, MSC
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cellsBiological
Also called FURESTEM-CD Inj.
IV infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
all kinds of adverse events which occur during the clinical sutdy
Safety outcome
Measured: 114 weeks
Secondary outcomes (2)
ratio of patients who is applicable to CDAI<150
Efficacy outcome
Measured: 114 weeks
ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7)
Efficacy outcome
Measured: 114 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2021 (estimated)
- Study completionNov 2021 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kang Stem Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suk-kyun Yang, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926300
- Sponsor's protocol ID
- KSTHD_FURESTEM-CD-EXT
- Status last verified
- Sep 2016
- First submitted
- 11 Nov 2015
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study, An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trials to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT02926300
- Acronym / sponsor ID
- KSTHD_FURESTEM-CD-EXT
- Conditions
- Crohn's Disease
- Keywords
- crohn's disease, stem cell therapy, inflammatory bowel disease, hUCB-MSC, UCB-MSC, Umbilical cord Blood, Rheumatoid Arthritis, RA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 6 Oct 2016 (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.
The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients who has history of FURESTEM-CD injection at least once.
Detailed description
This study is an extended study of KSTHD_FURESTEM-CD phase 1 / 2a clinical trials in patients with moderate active Crohn's disease who had received at least once a FURESTEM-CD injection. The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients for approximately 36 months (144 weeks).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gender: Both Age Limits: 19years to 70years Healthy Volunteers?: No.
Key inclusion criteria (2 listed)
- patients who has history of FURESTEM-CD Inj. injection at least once.
- patients who understand and voluntarily sign an informed consent form.
Key exclusion criteria (1 listed)
- any other condition which the Principle Investigator judges would make subject unsuitable for study participation.
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 |
|---|---|---|
| stem cellsAlso: FURESTEM-CD Inj.IV infusion | Biological | – |
Primary outcome
all kinds of adverse events which occur during the clinical sutdy
Time frame: 114 weeks
Safety outcome
2 secondary outcomes
ratio of patients who is applicable to CDAI<150
Time frame: 114 weeks
ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7)
Time frame: 114 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
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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.
Eun-ji Kang contact
Suk-kyun Yang principal investigator
Asan Medical Center
7 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's Disease, run by Kang Stem Biotech Co., Ltd. at 7 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: status not confirmed, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun-ji Kang (ejkang@kangstem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all kinds of adverse events which occur during the clinical sutdy (time frame: 114 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 6 Sep 2017.