Fecal IncontinencePhase 1NCT02384499
Treatment of Fecal Incontinence Using Allogenic-Adipose-derived Mesenchymal Stem Cells: A Prospective, Dose Escalation, Randomized, Placebo-controlled, Parallel-group, Single-blind, Single-center Pilot Study
A Phase 1 study testing ALLO-ASC injection in people with Fecal Incontinence, run by Yonsei University at 1 site in South Korea.
Trial summary
Purpose: The investigators aimed to investigate the safety and efficacy in the treatment of fecal incontinence by injection of ALLO-ASC into the anal sphincter. Method 1. Safety test of allogenic ASCs injection 2. Efficacy test of allogenic ASCs injection Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- ALLO-ASC injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to 30 Jun 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 19 years old
- Patients who received either medical therapy or biofeedback for fecal incontinence for more than 2 months with Wexner score ≥ 8
- Transanal ultrasonography: presents a continuous fashion of anal sphincter
- Anal manometery: decreased anal pressures than normal level
- Negative for urine β-hCG in the screening test
- An informed consent form has been signed by the patient
Who cannot join
- Participation in another clinical trial within 30 days
- History of anorectal surgery within the previous 6 months
- History of malignant tumor surgery within the previous 5 years (except for carcinoma in situ)
- Patients requiring anorectal surgical treatments
- History of artificial sphincter surgery
- History of vaginal delivery within 6 months
Show all 17Show fewer
- Medical history of variant Creutzfeld-Jakobs disease or related diseases
- Allergy to bovine-derived materials, fibrin glue or anesthestics
- Autoimmune disease
- Active tuberculosis
- Pregnant or breastfeeding women
- Unwillingness to use contraceptive methods
- Patients with inflammatory bowel disease
- Alcohol or drug-abuse
- Use of cytotoxic agents within 30 days
- Patients who have severe constipation (<2 times/week), anal fistula, rectal prolapse, spinal cord injury, multiple sclerosis, Parkinson's disease
- Patients with one of hematologic disease, immunodeficieny, fever, acute disease or severe chronic disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Section of Colon and Rectal Surger, Department of Surgery, Yonsei University College of Medicine
Seoul, 135-720
About this study
- Purpose: The investigators aimed to investigate the safety and efficacy in the treatment of fecal incontinence by injection of ALLO-ASC into the anal sphincter.
- Method
- Safety test of allogenic ASCs injection
- Efficacy test of allogenic ASCs injection
Read the detailed description
- Background: Fecal incontinence is a distressing condition with recurrent uncontrolled passage of fecal material. Although fecal incontinence is developed by multifactorial causes, treatments were limited in medical or surgical methods. According to the recent studies of stem cell regeneration, it is reported that human adipose-derived stem cells have plentiful capacity in muscle regeneration, which had the efficacy to treat Crohn's fistulas. Therefore, the investigators hypothesized that the capability of muscle regeneration of allogenic-adipose-derived mesenchymal stem cells (ALLO-ASC) can be used to treat degenerated anal sphincter, which leads to fecal incontinence.
- Purpose:The investigators aimed to investigate the safety and efficacy in the treatment of fecal incontinence by injection of ALLO-ASC into the anal sphincter.
- Method
- Safety test of allogenic ASCs injection In the first year, the investigators will investigate the safety of ALLO-ASC injection by a dose escalation study. Patients are sequentially enrolled into three groups, which are composed of three patients each. They are treated with an injection of ALLO-ASC to the anal sphincter for 3x107 cells/ml (group 1), 6x107 cells/ml (group 2), 9x107 cells/ml (group 3), respectively. After receiving the ALLO-ASC injection, patients will receive a physical examination, a serologic and immunologic response test (CD4/CD8) with an assessment of the Wexner score, patient satisfaction survey, WHO toxicity scale, adverse events, anorectal manometry and endorectal ultrasound at 1, 4, 8 weeks, 4, 6, 9, and 12 months in the outpatient clinic. The response of ALLO-ASC injection is assessed at 8 weeks after an injection and the most effective dose is determined among the groups.
- Efficacy test of allogenic ASCs injection In the second year, the investigators will assess the efficacy of the ALLO-ASC injection comparing the ALLO-ASC injection group and the placebo group (0.9% normal saline injection) by a randomized, open-label, single-blind design. Each group is composed of six patients. Both the clinical assessment and follow-up period are identical with the first-year protocol.
- Conditions
- Fecal Incontinence
- Being tested
- ALLO-ASC injection, Placebo
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLO-ASC injectionBiological
Also called ALLO-ASC
Allogenic-adipose-derived mesenchymal stem cells (ALLO-ASC) injection to the anal sphincter of patients with fecal incontinence
PlaceboDrug
Also called Normal saline with fibrin glue injection
0.9% normal saline with fibrin glue injection to the anal sphincter of patients with fecal incontinence
| Study group | Role | What they receive |
|---|---|---|
| ALLO-ASC group | Experimental | Allogenic-adipose-derived mesenchymal stem cell (ALLO-ASC) with fibrin glue injection to the anal sphincter Receives: Biological: ALLO-ASC injection |
| Normal saline group | Placebo comparator | 0.9% normal saline with fibrin glue injection to the anal sphincter Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically measured abnormality of laboratory tests and adverse events
The investigators will assess the safety of allogenic-adipose-derived mesenchymal stem cell (ALLO-ASC) injection to the anal sphincter among the three experimental groups (group 1: 3x107 cells/ml; group 2: 6x107 cells/ml; group 3: 9x107 cells/ml)).
Measured: one year (12 months)
Secondary outcomes (1)
Satisfaction as measured by Wexner Score
Improvement of Wexner Score at 12 months compared to baseline per each group. (The investigators will assess the efficacy of the ALLO-ASC injection comparing the ALLO-ASC injection group and the placebo group (0.9% normal saline injection) by a randomized, open-label, single-blind design.)
Measured: one year (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startDec 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384499
- Sponsor's protocol ID
- 3-2014-0271
- Status last verified
- Aug 2018
- First submitted
- 24 Feb 2015
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
White AB, Keller PW, Acevedo JF, Word RA, Wai CY. Effect of myogenic stem cells on contractile properties of the repaired and unrepaired transected external anal sphincter in an animal model. Obstet Gynecol. 2010 Apr;115(4):815-823. doi: 10.1097/AOG.0b013e3181d56cc5.
PubMed 20308844Parmar N, Kumar L, Emmanuel A, Day RM. Prospective regenerative medicine therapies for obstetric trauma-induced fecal incontinence. Regen Med. 2014;9(6):831-40. doi: 10.2217/rme.14.56.
PubMed 25431918Kang SB, Lee HN, Lee JY, Park JS, Lee HS, Lee JY. Sphincter contractility after muscle-derived stem cells autograft into the cryoinjured anal sphincters of rats. Dis Colon Rectum. 2008 Sep;51(9):1367-73. doi: 10.1007/s10350-008-9360-y. Epub 2008 Jun 7.
PubMed 18536965Lorenzi B, Pessina F, Lorenzoni P, Urbani S, Vernillo R, Sgaragli G, Gerli R, Mazzanti B, Bosi A, Saccardi R, Lorenzi M. Treatment of experimental injury of anal sphincters with primary surgical repair and injection of bone marrow-derived mesenchymal stem cells. Dis Colon Rectum. 2008 Apr;51(4):411-20. doi: 10.1007/s10350-007-9153-8. Epub 2008 Jan 26.
PubMed 18224375Garcia-Olmo D, Herreros D, Pascual I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009 Jan;52(1):79-86. doi: 10.1007/DCR.0b013e3181973487.
PubMed 19273960Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.
PubMed 10813117Park EJ, Kang J, Baik SH. Treatment of faecal incontinence using allogeneic-adipose-derived mesenchymal stem cells: a study protocol for a pilot randomised controlled trial. BMJ Open. 2016 Feb 17;6(2):e010450. doi: 10.1136/bmjopen-2015-010450.
PubMed 26888731
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Fecal Incontinence Using Allogenic-Adipose-derived Mesenchymal Stem Cells: A Prospective, Dose Escalation, Randomized, Placebo-controlled, Parallel-group, Single-blind, Single-center Pilot Study
- ClinicalTrials.gov ID
- NCT02384499
- Acronym / sponsor ID
- 3-2014-0271
- Conditions
- Fecal Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 10 Mar 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.
- Purpose: The investigators aimed to investigate the safety and efficacy in the treatment of fecal incontinence by injection of ALLO-ASC into the anal sphincter.
- Method
- Safety test of allogenic ASCs injection
- Efficacy test of allogenic ASCs injection
Detailed description
- Background: Fecal incontinence is a distressing condition with recurrent uncontrolled passage of fecal material. Although fecal incontinence is developed by multifactorial causes, treatments were limited in medical or surgical methods. According to the recent studies of stem cell regeneration, it is reported that human adipose-derived stem cells have plentiful capacity in muscle regeneration, which had the efficacy to treat Crohn's fistulas. Therefore, the investigators hypothesized that the capability of muscle regeneration of allogenic-adipose-derived mesenchymal stem cells (ALLO-ASC) can be used to treat degenerated anal sphincter, which leads to fecal incontinence.
- Purpose:The investigators aimed to investigate the safety and efficacy in the treatment of fecal incontinence by injection of ALLO-ASC into the anal sphincter.
- Method
- Safety test of allogenic ASCs injection In the first year, the investigators will investigate the safety of ALLO-ASC injection by a dose escalation study. Patients are sequentially enrolled into three groups, which are composed of three patients each. They are treated with an injection of ALLO-ASC to the anal sphincter for 3x107 cells/ml (group 1), 6x107 cells/ml (group 2), 9x107 cells/ml (group 3), respectively. After receiving the ALLO-ASC injection, patients will receive a physical examination, a serologic and immunologic response test (CD4/CD8) with an assessment of the Wexner score, patient satisfaction survey, WHO toxicity scale, adverse events, anorectal manometry and endorectal ultrasound at 1, 4, 8 weeks, 4, 6, 9, and 12 months in the outpatient clinic. The response of ALLO-ASC injection is assessed at 8 weeks after an injection and the most effective dose is determined among the groups.
- Efficacy test of allogenic ASCs injection In the second year, the investigators will assess the efficacy of the ALLO-ASC injection comparing the ALLO-ASC injection group and the placebo group (0.9% normal saline injection) by a randomized, open-label, single-blind design. Each group is composed of six patients. Both the clinical assessment and follow-up period are identical with the first-year protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLO-ASC group | Experimental | Biological: ALLO-ASC injectionAllogenic-adipose-derived mesenchymal stem cell (ALLO-ASC) with fibrin glue injection to the anal sphincter |
| Normal saline group | Placebo comparator | Drug: Placebo0.9% normal saline with fibrin glue injection to the anal sphincter |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 19 years old
- Patients who received either medical therapy or biofeedback for fecal incontinence for more than 2 months with Wexner score ≥ 8
- Transanal ultrasonography: presents a continuous fashion of anal sphincter
- Anal manometery: decreased anal pressures than normal level
- Negative for urine β-hCG in the screening test
Key exclusion criteria (17 listed)
- Participation in another clinical trial within 30 days
- History of anorectal surgery within the previous 6 months
- History of malignant tumor surgery within the previous 5 years (except for carcinoma in situ)
- Patients requiring anorectal surgical treatments
- History of artificial sphincter surgery
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 injectionAlso: ALLO-ASCAllogenic-adipose-derived mesenchymal stem cells (ALLO-ASC) injection to the anal sphincter of patients with fecal incontinence | Biological | ALLO-ASC group |
| PlaceboAlso: Normal saline with fibrin glue injection0.9% normal saline with fibrin glue injection to the anal sphincter of patients with fecal incontinence | Drug | Normal saline group |
Primary outcome
Clinically measured abnormality of laboratory tests and adverse events
Time frame: one year (12 months)
The investigators will assess the safety of allogenic-adipose-derived mesenchymal stem cell (ALLO-ASC) injection to the anal sphincter among the three experimental groups (group 1: 3x107 cells/ml; group 2: 6x107 cells/ml; group 3: 9x107 cells/ml)).
1 secondary outcome
Satisfaction as measured by Wexner Score
Time frame: one year (12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Background: PubMed 20308844White AB, Keller PW, Acevedo JF, Word RA, Wai CY. Effect of myogenic stem cells on contractile properties of the repaired and unrepaired transected external anal sphincter in an animal model. Obstet Gynecol. 2010 Apr;115(4):815-823. doi: 10.1097/AOG.0b013e3181d56cc5.
- Background: PubMed 25431918Parmar N, Kumar L, Emmanuel A, Day RM. Prospective regenerative medicine therapies for obstetric trauma-induced fecal incontinence. Regen Med. 2014;9(6):831-40. doi: 10.2217/rme.14.56.
- Background: PubMed 18536965Kang SB, Lee HN, Lee JY, Park JS, Lee HS, Lee JY. Sphincter contractility after muscle-derived stem cells autograft into the cryoinjured anal sphincters of rats. Dis Colon Rectum. 2008 Sep;51(9):1367-73. doi: 10.1007/s10350-008-9360-y. Epub 2008 Jun 7.
- Background: PubMed 18224375Lorenzi B, Pessina F, Lorenzoni P, Urbani S, Vernillo R, Sgaragli G, Gerli R, Mazzanti B, Bosi A, Saccardi R, Lorenzi M. Treatment of experimental injury of anal sphincters with primary surgical repair and injection of bone marrow-derived mesenchymal stem cells. Dis Colon Rectum. 2008 Apr;51(4):411-20. doi: 10.1007/s10350-007-9153-8. Epub 2008 Jan 26.
- Background: PubMed 19273960Garcia-Olmo D, Herreros D, Pascual I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009 Jan;52(1):79-86. doi: 10.1007/DCR.0b013e3181973487.
- Background: PubMed 10813117Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.
- Derived from this study: PubMed 26888731Park EJ, Kang J, Baik SH. Treatment of faecal incontinence using allogeneic-adipose-derived mesenchymal stem cells: a study protocol for a pilot randomised controlled trial. BMJ Open. 2016 Feb 17;6(2):e010450. doi: 10.1136/bmjopen-2015-010450.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 injection in people with Fecal Incontinence, run by Yonsei University 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 13 Aug 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinically measured abnormality of laboratory tests and adverse events (time frame: one year (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02384499, which also lists 7 linked publications.
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 13 Aug 2018.