Anal FistulaPhase 2NCT00115466
Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
A Phase 2 study testing Non-surgical autologous implant of ASCs in people with Anal Fistula, run by Cellerix at 1 site in Spain.
Trial summary
This comparative, multicentre, randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the non-surgical treatment of complex perianal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Non-surgical autologous implant of ASCs
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2004to Jul 2006
- Phase
- Phase 2
- 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
Who may be able to join
- Patients of both sexes older than 18 years of age.
- Patients with a complex perianal fistula pathology which we define as the subjects that fulfil some of the following conditions:
- No palpation of the fistula tract beneath the perianal skin.
- A tract that is parallel to the rectum on exploration with a stylet.
- Associated faecal incontinence.
- Risk factors of anal incontinence.
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- At least one previous operation for a fistulous disorder.
- Suprasphincteric trajectories
- Rectovaginal fistula
- Prior diagnosis of Crohn's disease.
- Patients from whom written informed consent has been obtained for them to participate in the study prior to performing any procedure described in the study.
- Patients that have already been subjected to a colonoscopy within a period of up to 6 months prior to the study.
Who cannot join
- Patients that are extremely thin who should not be subjected to liposuction.
- Known allergy to local anaesthetics or to bovine proteins
- History of neoplasia in the past 5 years.
- Patients with a diagnosis of active Tuberculosis at the moment of inclusion.
- Patients with prior positive markers for any of the following pathogens: Hepatitis B and C, HIV-1 or HIV-2.
- Any other medical condition that in the judgement of the investigator could interfere with their optimal participation in the study or produce a significant risk to the patient.
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- Patients that have participated in another study in the 30 days prior to this one or that have planned to participate simultaneously in another study.
- Patients that have not given their informed consent to participate in this study.
- Psychiatric disorder or other factors that in the judgement of the investigator could complicate the participation of the patient in the study.
- Breast feeding, gestation or intention to become pregnant up to 6 months after finalising their participation in the study, or that are not using adequate methods of contraception during the same period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Trial, Multicentre, Randomised and Comparative, to Evaluate the Efficacy and Safety of a New Therapy With Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
This comparative, multicentre, randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the non-surgical treatment of complex perianal fistula.
Read the detailed description
Comparative, multicentre, randomised clinical trial, designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the NON-SURGICAL treatment of complex perianal fistula. The closure/healing of the fistula will be evaluated periodically, and it will be considered completely closed if there is no suppuration from the external orifice and re-epithelialisation can be observed at 8 weeks after the administration of the randomised therapy.
- Conditions
- Anal Fistula
- Being tested
- Non-surgical autologous implant of ASCs
- Keywords
- ASCs (adult stem cells derived from adipose tissue), Fistula, Cell Therapy, Complex perianal fistula
- Medical subject headings
- Rectal Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical autologous implant of ASCsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization)
Secondary outcomes (1)
No fistula recurrence after 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2005 (estimated)
- Study startOct 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Cellerix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Damian Garcia-Olmo, Prof., Principal investigator, Cellerix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115466
- Sponsor's protocol ID
- GX401/TCFIS
- Other IDs
- Nr. 04-0211
- Status last verified
- Jun 2005
- First submitted
- 22 Jun 2005
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy. Int J Colorectal Dis. 2003 Sep;18(5):451-4. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20.
PubMed 12756590
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial, Multicentre, Randomised and Comparative, to Evaluate the Efficacy and Safety of a New Therapy With Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
- ClinicalTrials.gov ID
- NCT00115466
- Acronym / sponsor ID
- GX401/TCFIS
- Conditions
- Anal Fistula
- Keywords
- ASCs (adult stem cells derived from adipose tissue), Fistula, Cell Therapy, Complex perianal fistula
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- CellerixIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Jul 2006
- First posted
- 23 Jun 2005 (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 comparative, multicentre, randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the non-surgical treatment of complex perianal fistula.
Detailed description
Comparative, multicentre, randomised clinical trial, designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the NON-SURGICAL treatment of complex perianal fistula. The closure/healing of the fistula will be evaluated periodically, and it will be considered completely closed if there is no suppuration from the external orifice and re-epithelialisation can be observed at 8 weeks after the administration of the randomised therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients of both sexes older than 18 years of age.
- Patients with a complex perianal fistula pathology which we define as the subjects that fulfil some of the following conditions:
- Patients from whom written informed consent has been obtained for them to participate in the study prior to performing any procedure described in the study.
- Patients that have already been subjected to a colonoscopy within a period of up to 6 months prior to the study.
Key exclusion criteria (10 listed)
- Patients that are extremely thin who should not be subjected to liposuction.
- Known allergy to local anaesthetics or to bovine proteins
- History of neoplasia in the past 5 years.
- Patients with a diagnosis of active Tuberculosis at the moment of inclusion.
- Patients with prior positive markers for any of the following pathogens: Hepatitis B and C, HIV-1 or HIV-2.
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 |
|---|---|---|
| Non-surgical autologous implant of ASCs | Procedure or surgery | – |
Primary outcome
Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization)
1 secondary outcome
No fistula recurrence after 1 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Results publication: PubMed 12756590Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy. Int J Colorectal Dis. 2003 Sep;18(5):451-4. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20.
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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
Cellerix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Non-surgical autologous implant of ASCs in people with Anal Fistula, run by Cellerix 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 12 inclusion and 10 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 24 Jun 2005. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization). 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 NCT00115466, which also lists 1 linked publication.
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 24 Jun 2005.