Perianal FistulaANTGNCT01623453
Follow-up Study of Autologous Adipose-derived Stem Cells (ANTG-ASC) for the Complex Fistula (ANTG-ASC-211)
An observational study of Perianal Fistula and Primary; Complex, run by Anterogen Co., Ltd. at 2 sites in South Korea.
Trial summary
This is an open follow-up clinical trial to evaluate a sustained efficacy and safety of ANTG-ASC injection for 4 months (6 months after final dose injection) after Phase II clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Fistula, Primary; Complex
- What is being tested?
- Autologous adipose derived stem cells(low dose group) and Autologous adipose derived stem cells(high dose group)
- Type of treatment
- Injection or infusion
- How many people
- 6 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2010to Sep 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: • the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials
Who may be able to join
- the patients who have participated in ANTG-ASC-210 clinical trial
- the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials
- the patients who submit written informed consents and is able to obey requirements of trials
Who cannot join
- a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
- a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
- a patient who has an autoimmune disease
- a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- a patient who has a symptom of septicemia or active tuberculosis (contain tuberculosis of anus and rectum)
- a patient who is pregnant or breast feeding
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- a patient who is not willing to use effective contraceptive methods during the study
- a patient who has inflammatory Bowel disease
- a patient who is sensitive to fibrin glue
- a patient who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker (who smoked more than 20 cigarettes a day)
- a patient who is not able to understand the objective of this study or to comply with the study requirements
- a patient who is considered to have a significant disease which can impact the study by investigator
- a patient who is considered not suitable for the study by investigator
- a patient who had a history of surgery for malignant tumor within the last five years (except carcinoma in situ)
- a patient who has multisystemic wasting syndrome (such as tuberculosis, Diabetes, Thyroid disorders, tumor, etc.)
- a patient who has taken cytotoxic drugs (such as immunosuppressants, corticosteroid, cytotoxic chemotherapy, anticoagulants, etc.) during long-term
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
DaeHang Hospital
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Follow-up Study to Evaluate the Sustained Healing Effect the Patients Who Showed Complete Closure of Fistula the Previous ANTG-ASC-210 Study
This is an open follow-up clinical trial to evaluate a sustained efficacy and safety of ANTG-ASC injection for 4 months (6 months after final dose injection) after Phase II clinical trial.
- Conditions
- Perianal Fistula, Primary; Complex
- Being tested
- Autologous adipose derived stem cells(low dose group), Autologous adipose derived stem cells(high dose group)
- Keywords
- crohn's disease, fistula, complex
- Medical subject headings
- Crohn Disease, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose derived stem cells(low dose group)Biological
Also called mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group 1: low dose group
low dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
Autologous adipose derived stem cells(high dose group)Biological
Also called mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group 2: high dose group
high dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Group1. Low dose group Receives: Biological: Autologous adipose derived stem cells(low dose group) | |
| High dose group | Group2. High dose group Receives: Biological: Autologous adipose derived stem cells(high dose group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Sustained efficacy of complete closure of fistula
Proportion of patients with completely closed of fistula (Month 4)
Measured: Month 4
Secondary outcomes (4)
Number of patients with sustained efficacy of closure of fistula
Proportion of patients with completely closed of fistula (Month 2)
Proportion of patients with more than 50% closed of fistula (Month 2, 4)
Measured: Month 2, 4
Evaluation of Fecal Incontinence Score
Evaluation of Fecal Incontinence Score (Wexner Score, Cleveland Clinic Continence Scoring System)
Measured: Month 4
Grade of Investigator's satisfaction
Grade of Investigator's satisfaction (Month 2, 4)
- very satisfied
- satisfied
- moderately satisfied
- dissatisfied
- very dissatisfied
Measured: Month 2, 4
Number of patients with adverse events as a measure of systemic tolerance and physical examinations
- systemic tolerance (Month 4) (Biochemistry: Albumin, Alkaline phosphatase, ALT, AST, Bilirubin, Calcium, Chloride, Bicarbonate, Creatinine, Glucose, LDH, Potassium, Sodium, Total protein, Urea nitrogen(BUN), Uric acid / Hematology: Hemoglobin, Hematocrit, Reticulocyte count, complete blood cell count with differential, platelet count, WBC with differential count, ESR, PT/APTT)
- Physical examination
- Pregnancy testing (Month 4)
Measured: Month 2, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startSep 2010
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Difficulty recruiting subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal FistulaStudies 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
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KJ Park, Principal investigator, Seoul National University HospitalDS Kim, Principal investigator, Daehang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623453
- Sponsor's protocol ID
- ANTG-ASC-211
- Acronym
- ANTG
- Status last verified
- Jun 2012
- First submitted
- 8 Jun 2012
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Study to Evaluate the Sustained Healing Effect the Patients Who Showed Complete Closure of Fistula the Previous ANTG-ASC-210 Study
- ClinicalTrials.gov ID
- NCT01623453
- Acronym / sponsor ID
- ANTG / ANTG-ASC-211
- Conditions
- Perianal Fistula, Primary; Complex
- Keywords
- crohn's disease, fistula, complex
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting subjects
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Jun 2012 (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 an open follow-up clinical trial to evaluate a sustained efficacy and safety of ANTG-ASC injection for 4 months (6 months after final dose injection) after Phase II clinical trial.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose group | – | Biological: Autologous adipose derived stem cells(low dose group)Group1. Low dose group |
| High dose group | – | Biological: Autologous adipose derived stem cells(high dose group)Group2. High dose group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- • the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials
Key inclusion criteria (3 listed)
- the patients who have participated in ANTG-ASC-210 clinical trial
- the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials
- the patients who submit written informed consents and is able to obey requirements of trials
Key exclusion criteria (16 listed)
- a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
- a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
- a patient who has an autoimmune disease
- a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- a patient who has a symptom of septicemia or active tuberculosis (contain tuberculosis of anus and rectum)
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 |
|---|---|---|
| Autologous adipose derived stem cells(low dose group)Also: mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group 1: low dose grouplow dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage. | Biological | Low dose group |
| Autologous adipose derived stem cells(high dose group)Also: mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group 2: high dose grouphigh dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage. | Biological | High dose group |
Primary outcome
Number of patients with Sustained efficacy of complete closure of fistula
Time frame: Month 4
Proportion of patients with completely closed of fistula (Month 4)
4 secondary outcomes
Number of patients with sustained efficacy of closure of fistula
Time frame: Month 2, 4
Evaluation of Fecal Incontinence Score
Time frame: Month 4
Grade of Investigator's satisfaction
Time frame: Month 2, 4
Number of patients with adverse events as a measure of systemic tolerance and physical examinations
Time frame: Month 2, 4
Results and safety
The study was stopped early (reason given: Difficulty recruiting subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- 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. This study is not recruiting at the moment.
KJ Park principal investigator
Seoul National University Hospital
DS Kim principal investigator
Daehang Hospital
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 Perianal Fistula and Primary; Complex, 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 3 inclusion and 16 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: stopped early, as of the sponsor's last update on 23 Nov 2016. 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?
The study was stopped early (reason given: Difficulty recruiting subjects). Results are not available in the source record.
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?
Number of patients with Sustained efficacy of complete closure of fistula (time frame: Month 4). 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 23 Nov 2016.