Rectovaginal FistulaPhase 1/2ALOREVANCT00999115
Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA)
A Phase 1/2 study testing Expanded allogenic adipose-derived adult stem cells in people with Rectovaginal Fistula and Crohn Disease, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz at 1 site in Spain.
Trial summary
The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rectovaginal Fistula, Crohn Disease
- What is being tested?
- Expanded allogenic adipose-derived adult stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2009to Dec 2011
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Patients with Crohn´s disease diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomopathological and/or radiologic criteria.
- Fulfilling one of the following criteria:
- At least, one previous surgery for fistulous disease.
- Physical status which discourage liposuction.
- Rectovaginal fistula.
- Women of a childbearing age. Good general state of health according to the findings of the clinical history and the physical examination.
Who cannot join
- Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active luminal disease requiring immediate therapy, assessed by rectosigmoidoscopy
- Patients with CDAI≥201
- Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
- Patients who have received infliximab or any other anti TNF agent in the 8 weeks before the cell treatment administration
- Patients who have received tacrolimus or cyclosporine in the 4 weeks before the cell treatment administration
- Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
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- Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years
- Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.
- Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
- Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent.
- Patients allergic to local anesthetics or gadolinium (MRI contrast) MRI is unfeasible (e.g. due to the presence of pacemakers, hip replacements or severe claustrophobia)
- Patients who have suffering major surgery or severe trauma in the prior 6 months
- Pregnant or breastfeeding women
- Patients currently receiving, or having received within 1 month prior to enrolment into this clinical trial, any investigational drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial in Phase I-IIa to Study the Feasibility and Security of the Allogenic Use of Adipose-derived Stem Cells for the Local Treatment of Recto-vaginal Fistula in Crohn´s Disease
The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.
- Conditions
- Rectovaginal Fistula, Crohn Disease
- Being tested
- Expanded allogenic adipose-derived adult stem cells
- Keywords
- Rectovaginal Fistula, Crohn Disease, Allogenic, Adipose-Derived Stem Cells
- Medical subject headings
- Rectovaginal Fistula, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded allogenic adipose-derived adult stem cellsDrug
Also called CX601 (company code)
Administration will be preceded by localization and closure of the internal opening. Cell treatment injection will be performed following Major Ambulatory Surgery standards. Patients will receive an intralesional dose of 20 million cells at baseline. 50% of the cell suspension will be placed into fistula walls of the internal opening, with the remaining 50% being injected across the wall tracts of the target fistula. Patients without healing (complete fistula closure)at week 12 will receive a second dose of 40 million cells, using the same treatment approach.
| Study group | Role | What they receive |
|---|---|---|
| Allogenic ASCs | Experimental | Intralesional dose of 20 million cells at baseline with a possible second administration of 40 million in case of incomplete fistula closure following week 12 assessment. Receives: Drug: Expanded allogenic adipose-derived adult stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed
Measured: 12 weeks
Secondary outcomes (4)
Quality of life assessment using the SF-36 questionnaire
Measured: 12 weeks
Adverse events
Measured: 1, 4, 8,12, 24, 54 weeks
Clinically relevant variations in laboratory test
Measured: 1, 4 8, 12, 24, 54 weeks
Quality of life assessment using the SF-36 questionnaire
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rectovaginal 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
- Investigators
- Damián García Olmo, MD, Principal investigator, General Surgery Department, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999115
- Sponsor's protocol ID
- EC08/00153
- Other IDs
- EudraCT: 2009-010225-39
- Acronym
- ALOREVA
- Status last verified
- Jan 2012
- First submitted
- 20 Oct 2009
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- 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 12756590Garcia-Olmo D, Garcia-Arranz M, Herreros D, Pascual I, Peiro C, Rodriguez-Montes JA. A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum. 2005 Jul;48(7):1416-23. doi: 10.1007/s10350-005-0052-6.
PubMed 15933795Garcia-Olmo D, Herreros D, Pascual M, Pascual I, De-La-Quintana P, Trebol J, Garcia-Arranz M. Treatment of enterocutaneous fistula in Crohn's Disease with adipose-derived stem cells: a comparison of protocols with and without cell expansion. Int J Colorectal Dis. 2009 Jan;24(1):27-30. doi: 10.1007/s00384-008-0559-0. Epub 2008 Aug 12.
PubMed 18696086Garcia-Olmo D, Garcia-Arranz M, Herreros D. Expanded adipose-derived stem cells for the treatment of complex perianal fistula including Crohn's disease. Expert Opin Biol Ther. 2008 Sep;8(9):1417-23. doi: 10.1517/14712598.8.9.1417.
PubMed 18694359Garcia-Arranz M, Herreros MD, Gonzalez-Gomez C, de la Quintana P, Guadalajara H, Georgiev-Hristov T, Trebol J, Garcia-Olmo D. Treatment of Crohn's-Related Rectovaginal Fistula With Allogeneic Expanded-Adipose Derived Stem Cells: A Phase I-IIa Clinical Trial. Stem Cells Transl Med. 2016 Nov;5(11):1441-1446. doi: 10.5966/sctm.2015-0356. Epub 2016 Jul 13.
PubMed 27412883
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial in Phase I-IIa to Study the Feasibility and Security of the Allogenic Use of Adipose-derived Stem Cells for the Local Treatment of Recto-vaginal Fistula in Crohn´s Disease
- ClinicalTrials.gov ID
- NCT00999115
- Acronym / sponsor ID
- ALOREVA / EC08/00153
- Conditions
- Rectovaginal Fistula, Crohn Disease
- Keywords
- Rectovaginal Fistula, Crohn Disease, Allogenic, Adipose-Derived Stem Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la PazUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Oct 2009 (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 study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogenic ASCs | Experimental | Drug: Expanded allogenic adipose-derived adult stem cellsIntralesional dose of 20 million cells at baseline with a possible second administration of 40 million in case of incomplete fistula closure following week 12 assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent.
- Patients with Crohn´s disease diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomopathological and/or radiologic criteria.
- Fulfilling one of the following criteria:
- Rectovaginal fistula.
- Women of a childbearing age. Good general state of health according to the findings of the clinical history and the physical examination.
Key exclusion criteria (14 listed)
- Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active luminal disease requiring immediate therapy, assessed by rectosigmoidoscopy
- Patients with CDAI≥201
- Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
- Patients who have received infliximab or any other anti TNF agent in the 8 weeks before the cell treatment administration
- Patients who have received tacrolimus or cyclosporine in the 4 weeks before the cell treatment administration
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 |
|---|---|---|
| Expanded allogenic adipose-derived adult stem cellsAlso: CX601 (company code)Administration will be preceded by localization and closure of the internal opening. Cell treatment injection will be performed following Major Ambulatory Surgery standards. Patients will receive an intralesional dose of 20 million cells at baseline. 50% of the cell suspension will be placed into fistula walls of the internal opening, with the remaining 50% being injected across the wall tracts of the target fistula. Patients without healing (complete fistula closure)at week 12 will receive a second dose of 40 million cells, using the same treatment approach. | Drug | Allogenic ASCs |
Primary outcome
Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed
Time frame: 12 weeks
4 secondary outcomes
Quality of life assessment using the SF-36 questionnaire
Time frame: 12 weeks
Adverse events
Time frame: 1, 4, 8,12, 24, 54 weeks
Clinically relevant variations in laboratory test
Time frame: 1, 4 8, 12, 24, 54 weeks
Quality of life assessment using the SF-36 questionnaire
Time frame: 24 weeks
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 26 Jan 2012.
- Background: 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.
- Background: PubMed 15933795Garcia-Olmo D, Garcia-Arranz M, Herreros D, Pascual I, Peiro C, Rodriguez-Montes JA. A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum. 2005 Jul;48(7):1416-23. doi: 10.1007/s10350-005-0052-6.
- Background: PubMed 18696086Garcia-Olmo D, Herreros D, Pascual M, Pascual I, De-La-Quintana P, Trebol J, Garcia-Arranz M. Treatment of enterocutaneous fistula in Crohn's Disease with adipose-derived stem cells: a comparison of protocols with and without cell expansion. Int J Colorectal Dis. 2009 Jan;24(1):27-30. doi: 10.1007/s00384-008-0559-0. Epub 2008 Aug 12.
- Background: PubMed 18694359Garcia-Olmo D, Garcia-Arranz M, Herreros D. Expanded adipose-derived stem cells for the treatment of complex perianal fistula including Crohn's disease. Expert Opin Biol Ther. 2008 Sep;8(9):1417-23. doi: 10.1517/14712598.8.9.1417.
- Derived from this study: PubMed 27412883Garcia-Arranz M, Herreros MD, Gonzalez-Gomez C, de la Quintana P, Guadalajara H, Georgiev-Hristov T, Trebol J, Garcia-Olmo D. Treatment of Crohn's-Related Rectovaginal Fistula With Allogeneic Expanded-Adipose Derived Stem Cells: A Phase I-IIa Clinical Trial. Stem Cells Transl Med. 2016 Nov;5(11):1441-1446. doi: 10.5966/sctm.2015-0356. Epub 2016 Jul 13.
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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.
Damián García Olmo, MD principal investigator
General Surgery Department, Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Expanded allogenic adipose-derived adult stem cells in people with Rectovaginal Fistula and Crohn Disease, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz 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 7 inclusion and 14 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 26 Jan 2012. 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 combined 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.
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?
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?
Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed (time frame: 12 weeks). 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 NCT00999115, which also lists 5 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 26 Jan 2012.