Perianal FistulaRESCeCUFNCT03726255
Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula
An observational study of Perianal Fistula, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
This observational study aims at assessing the safety and efficacy profiles of mesenchymal stem cell, in different formats (SVF, autologous, allogenic), to treat complex perianal fistula according to the Spanish national Compassionate-use law . Read more about this study
- Who is it for?
- Ages 24 to 70 years
- Conditions the study is for
- Perianal Fistula
- What is being tested?
- Mesenchymal Stem Cell injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2014to 26 Jul 2018
- 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 24 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We present an observational study, including 52 cases (53% male and 47% female) treated by a compassionate use ASC program. The mean age was 45 years and ranged from 24 to 69 years. There were 42 perianal fistulas, 7 rectovaginal fistulas, 1 urethrorectal fistula, 1 sacral fistula and 1 hidradenitis suppurativa. All the cases had previous failed surgeries. Thirteen of fifty-two (25%) of the cases presented fecal incontinence at the moment of enrollment. 5/52 (9,6%) of the cases presented anal stenosis and 11/52 (21%) had a scaring anus.
Who may be able to join
- patients with complex perianal fistula
- patients who didn't meet criteria of the clinical trial (CT) in development
- foreign patients, who were not allowed to be included in the CT
- patients included in some CT control arms
- failure treatment in patients included in a CT treatment arm as a retreatment
Who cannot join
- not signature informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Investigación Sanitario Fundación Jiménez Díaz
Madrid, 28040
About this study
Official title: Retrospective Evaluation of Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula.
This observational study aims at assessing the safety and efficacy profiles of mesenchymal stem cell, in different formats (SVF, autologous, allogenic), to treat complex perianal fistula according to the Spanish national Compassionate-use law .
Read the detailed description
Under controlled circumstances, and approved by European and Spanish laws, a Compassionate-use Program allows the use of stem-cell therapy for patients with non-healing diseases, mostly complex fistula-in-ano, who do not meet criteria to be included in a clinical trial. Candidates had previously undergone multiple surgical interventions that had failed. The intervention consisted of surgery (with closure of the internal opening or a surgical flap performance), followed by stem cells injection. Three types of cells were used for implant: stromal vascular fraction, autologous expanded adipose-derived or allogenic adipose derived stem cells.
Healing was evaluated at 6th month follow-up. Outcome was classified as partial response or healing. Relapse was evaluated 1 year later. Maximum follow up period was 48 months.
- Conditions
- Perianal Fistula
- Being tested
- Mesenchymal Stem Cell injection
- Keywords
- Perianal fistula, compassionate use, mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cell injectionProcedure or surgery
curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)
| Study group | Role | What they receive |
|---|---|---|
| Stromal Vascular fraction | 31 patients were treated with one injection of Stromal Vascular Fraction from adipose tissue obtained by liposuction. Procedure: curettage, closure of the internal opening (IO) and SVF injection in IO (50%) and fistula tract (50%) Receives: Procedure: Mesenchymal Stem Cell injection | |
| Autologous mesenchymal stem cells | 9 patients were treated with one injection of autologous mesenchymal stem cells from adipose tissue. Procedure: curettage, closure of the internal opening (IO) and autologous cell injection in IO (50%) and fistula tract (50%) Receives: Procedure: Mesenchymal Stem Cell injection | |
| Allogenic mesenchymal stem cells | 12 patients were treated with one injection of allogenic mesenchymal stem cells of healthy donors: Procedure: curettage, closure of the internal opening (IO) and allogenic cell injection in IO (50%) and fistula tract (50%) Receives: Procedure: Mesenchymal Stem Cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with fistula healed
Complete closure of the fistula and epithelization of the external orifice
Measured: 12 months
Secondary outcomes (1)
Number of adversus events
general adversus events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Apr 2014
- Primary completion26 Jan 2018
- Study completion26 Jul 2018
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damian Garcia-Olmo, Prof., Principal investigator, Instituto de Investigación Sanitaria Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726255
- Sponsor's protocol ID
- EO166-18_FJD
- Acronym
- RESCeCUF
- Status last verified
- Oct 2018
- First submitted
- 26 Oct 2018
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula.
- ClinicalTrials.gov ID
- NCT03726255
- Acronym / sponsor ID
- RESCeCUF / EO166-18_FJD
- Conditions
- Perianal Fistula
- Keywords
- Perianal fistula, compassionate use, mesenchymal stem cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 31 Oct 2018 (actual)
- 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 observational study aims at assessing the safety and efficacy profiles of mesenchymal stem cell, in different formats (SVF, autologous, allogenic), to treat complex perianal fistula according to the Spanish national Compassionate-use law .
Detailed description
Under controlled circumstances, and approved by European and Spanish laws, a Compassionate-use Program allows the use of stem-cell therapy for patients with non-healing diseases, mostly complex fistula-in-ano, who do not meet criteria to be included in a clinical trial. Candidates had previously undergone multiple surgical interventions that had failed. The intervention consisted of surgery (with closure of the internal opening or a surgical flap performance), followed by stem cells injection. Three types of cells were used for implant: stromal vascular fraction, autologous expanded adipose-derived or allogenic adipose derived stem cells.
Healing was evaluated at 6th month follow-up. Outcome was classified as partial response or healing. Relapse was evaluated 1 year later. Maximum follow up period was 48 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stromal Vascular fraction | – | Procedure: Mesenchymal Stem Cell injection31 patients were treated with one injection of Stromal Vascular Fraction from adipose tissue obtained by liposuction. Procedure: curettage, closure of the internal opening (IO) and SVF injection in IO (50%) and fistula tract (50%) |
| Autologous mesenchymal stem cells | – | Procedure: Mesenchymal Stem Cell injection9 patients were treated with one injection of autologous mesenchymal stem cells from adipose tissue. Procedure: curettage, closure of the internal opening (IO) and autologous cell injection in IO (50%) and fistula tract (50%) |
| Allogenic mesenchymal stem cells | – | Procedure: Mesenchymal Stem Cell injection12 patients were treated with one injection of allogenic mesenchymal stem cells of healthy donors: Procedure: curettage, closure of the internal opening (IO) and allogenic cell injection in IO (50%) and fistula tract (50%) |
Who may qualify
- Ages
- 24 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We present an observational study, including 52 cases (53% male and 47% female) treated by a compassionate use ASC program. The mean age was 45 years and ranged from 24 to 69 years. There were 42 perianal fistulas, 7 rectovaginal fistulas, 1 urethrorectal fistula, 1 sacral fistula and 1 hidradenitis suppurativa. All the cases had previous failed surgeries. Thirteen of fifty-two (25%) of the cases presented fecal incontinence at the moment of enrollment. 5/52 (9,6%) of the cases presented anal stenosis and 11/52 (21%) had a scaring anus.
Key inclusion criteria (5 listed)
- patients with complex perianal fistula
- patients who didn't meet criteria of the clinical trial (CT) in development
- foreign patients, who were not allowed to be included in the CT
- patients included in some CT control arms
- failure treatment in patients included in a CT treatment arm as a retreatment
Key exclusion criteria (1 listed)
- not signature informed consent
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 |
|---|---|---|
| Mesenchymal Stem Cell injectioncurettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%) | Procedure or surgery | Allogenic mesenchymal stem cells, Autologous mesenchymal stem cells, Stromal Vascular fraction |
Primary outcome
Number of patients with fistula healed
Time frame: 12 months
Complete closure of the fistula and epithelization of the external orifice
1 secondary outcome
Number of adversus events
Time frame: 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 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Damian Garcia-Olmo, Prof. principal investigator
Instituto de Investigación Sanitaria Fundación Jiménez Díaz
1 site 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, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 5 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: finished, as of the sponsor's last update on 13 Nov 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 Spain. 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 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?
Number of patients with fistula healed (time frame: 12 months). 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 13 Nov 2018.