Extremely Complex Perianal FistulaePhase 2NCT01586715
Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)
A Phase 2 study testing Adipose-derived stem cells without expanded in people with Extremely Complex Perianal Fistulae, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the practicability of the autologous e-ASC (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant perianal fistulae. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extremely Complex Perianal Fistulae
- What is being tested?
- Adipose-derived stem cells without expanded
- 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
- Mar 2012to Dec 2013
- 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
- Signed informed consent
- Extremely Complex perianal fistulae
- Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
- Previous failure in at least one closing fistula standard treatment
Who cannot join
- Presence of severe proctitis or dominant active luminal disease requiring immediate therapy
- 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 with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
- 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
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- Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
- 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 enrollment into this clinical trial, any investigational drug
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Mariano A García Arranz, PhD, 0034 912071022, mgarciaa.hulp@salud.madrid.org
Damián García Olmo, Prof MD
About this study
Official title: A Phase IIa Clinical Trial to Study the Treatment of the Extremely Complex and Conventional Treatment Resistant Perianal Fistulae With Autologous Stem Cells From Lipoaspirate
The purpose of this study is to evaluate the practicability of the autologous e-ASC (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant perianal fistulae.
- Conditions
- Extremely Complex Perianal Fistulae
- Being tested
- Adipose-derived stem cells without expanded
- Keywords
- Extremely complex perianal fistula, Adipose Derived Stem Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-derived stem cells without expandedDrug
Administration will be intralesional injection of cells suspension. They will be placed into fistula walls
| Study group | Role | What they receive |
|---|---|---|
| Autologous Stem Cells | Experimental | Not described Receives: Drug: Adipose-derived stem cells without expanded |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of treatment of extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae
Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound
Measured: 16 weeks
Secondary outcomes (2)
Quality of life assessment using the SF-12 Questionnaire
Test SF-12 of quality of life
Measured: 1, 4, 16,24 weeks
Adverse events
Control by investigation team of CRD (data collections)
Measured: 1, 4, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Extremely Complex Perianal FistulaeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damián García Olmo, Prof MD, Principal investigator, General Surgery Department (Hospital Universitario La Paz) and Cell Therapy laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586715
- Sponsor's protocol ID
- HULPCIR-2010-01
- Other IDs
- 2010-024329-19
- Status last verified
- Apr 2012
- First submitted
- 23 Apr 2012
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bey NM. A new technique in dealing with superior rectovaginal fistulae. J. Obstrt Gynecol 1934. 41: 579-587
Given FT Jr. Rectovaginal fistula. A review of 20 years' experience in a community hospital. Am J Obstet Gynecol. 1970 Sep 1;108(1):41-6. No abstract available.
PubMed 4916866Daniels BT. Rectovaginal fistula: a clinical and pathological study. Doctoral dissertation. Minneapolis: University of Minnesota 1949
LAIRD DR. Procedures used in treatment of complicated fistulas. Am J Surg. 1948 Dec;76(6):701-8. doi: 10.1016/s0002-9610(48)90211-6. No abstract available.
PubMed 18895064Hoexter B, Labow SB, Moseson MD. Transanal rectovaginal fistula repair. Dis Colon Rectum. 1985 Aug;28(8):572-5. doi: 10.1007/BF02554145.
PubMed 4017820Fry RD, Shemesh EI, Kodner IJ, Timmcke A. Techniques and results in the management of anal and perianal Crohn's disease. Surg Gynecol Obstet. 1989 Jan;168(1):42-8.
PubMed 2909131Radcliffe AG, Ritchie JK, Hawley PR, Lennard-Jones JE, Northover JM. Anovaginal and rectovaginal fistulas in Crohn's disease. Dis Colon Rectum. 1988 Feb;31(2):94-9. doi: 10.1007/BF02562636.
PubMed 3338350Tuxen PA, Castro AF. Rectovaginal fistula in Crohn's disease. Dis Colon Rectum. 1979 Jan-Feb;22(1):58-62. doi: 10.1007/BF02586761. No abstract available.
PubMed 421652Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525.
PubMed 7429313Bandy LC, Addison A, Parker RT. Surgical management of rectovaginal fistulas in Crohn's disease. Am J Obstet Gynecol. 1983 Oct 15;147(4):359-63. doi: 10.1016/s0002-9378(16)32225-6.
PubMed 6624806Bauer JJ, Sher ME, Jaffin H, Present D, Gelerent I. Transvaginal approach for repair of rectovaginal fistulae complicating Crohn's disease. Ann Surg. 1991 Feb;213(2):151-8. doi: 10.1097/00000658-199102000-00010.
PubMed 1992942Tsang CB, Madoff RD, Wong WD, Rothenberger DA, Finne CO, Singer D, Lowry AC. Anal sphincter integrity and function influences outcome in rectovaginal fistula repair. Dis Colon Rectum. 1998 Sep;41(9):1141-6. doi: 10.1007/BF02239436.
PubMed 9749498Andreani SM, Dang HH, Grondona P, Khan AZ, Edwards DP. Rectovaginal fistula in Crohn's disease. Dis Colon Rectum. 2007 Dec;50(12):2215-22. doi: 10.1007/s10350-007-9057-7. Epub 2007 Sep 11.
PubMed 17846837García Olmo D, García-Verdugo JM, Alemany J, Gonzalez M, Gutierrez-Fuentes JA. CELL THERAPHY . Ed. Mac Graw Hill. Madrid 2007
Aggarwal S, Pittenger MF. Human mesenchymal stem cells modulate allogeneic immune cell responses. Blood. 2005 Feb 15;105(4):1815-22. doi: 10.1182/blood-2004-04-1559. Epub 2004 Oct 19.
PubMed 15494428
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Clinical Trial to Study the Treatment of the Extremely Complex and Conventional Treatment Resistant Perianal Fistulae With Autologous Stem Cells From Lipoaspirate
- ClinicalTrials.gov ID
- NCT01586715
- Acronym / sponsor ID
- HULPCIR-2010-01
- Conditions
- Extremely Complex Perianal Fistulae
- Keywords
- Extremely complex perianal fistula, Adipose Derived Stem Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 27 Apr 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.
The purpose of this study is to evaluate the practicability of the autologous e-ASC (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant perianal fistulae.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Stem Cells | Experimental | Drug: Adipose-derived stem cells without expanded |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Extremely Complex perianal fistulae
- Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
- Previous failure in at least one closing fistula standard treatment
Key exclusion criteria (10 listed)
- Presence of severe proctitis or dominant active luminal disease requiring immediate therapy
- 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 with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
- 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.
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 |
|---|---|---|
| Adipose-derived stem cells without expandedAdministration will be intralesional injection of cells suspension. They will be placed into fistula walls | Drug | Autologous Stem Cells |
Primary outcome
Safety of treatment of extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae
Time frame: 16 weeks
Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound
2 secondary outcomes
Quality of life assessment using the SF-12 Questionnaire
Time frame: 1, 4, 16,24 weeks
Adverse events
Time frame: 1, 4, 12, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
- BackgroundBey NM. A new technique in dealing with superior rectovaginal fistulae. J. Obstrt Gynecol 1934. 41: 579-587
- Background: PubMed 4916866Given FT Jr. Rectovaginal fistula. A review of 20 years' experience in a community hospital. Am J Obstet Gynecol. 1970 Sep 1;108(1):41-6. No abstract available.
- BackgroundDaniels BT. Rectovaginal fistula: a clinical and pathological study. Doctoral dissertation. Minneapolis: University of Minnesota 1949
- Background: PubMed 18895064LAIRD DR. Procedures used in treatment of complicated fistulas. Am J Surg. 1948 Dec;76(6):701-8. doi: 10.1016/s0002-9610(48)90211-6. No abstract available.
- Background: PubMed 4017820Hoexter B, Labow SB, Moseson MD. Transanal rectovaginal fistula repair. Dis Colon Rectum. 1985 Aug;28(8):572-5. doi: 10.1007/BF02554145.
- Background: PubMed 2909131Fry RD, Shemesh EI, Kodner IJ, Timmcke A. Techniques and results in the management of anal and perianal Crohn's disease. Surg Gynecol Obstet. 1989 Jan;168(1):42-8.
- Background: PubMed 3338350Radcliffe AG, Ritchie JK, Hawley PR, Lennard-Jones JE, Northover JM. Anovaginal and rectovaginal fistulas in Crohn's disease. Dis Colon Rectum. 1988 Feb;31(2):94-9. doi: 10.1007/BF02562636.
- Background: PubMed 421652Tuxen PA, Castro AF. Rectovaginal fistula in Crohn's disease. Dis Colon Rectum. 1979 Jan-Feb;22(1):58-62. doi: 10.1007/BF02586761. No abstract available.
- Background: PubMed 7429313Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525.
- Background: PubMed 6624806Bandy LC, Addison A, Parker RT. Surgical management of rectovaginal fistulas in Crohn's disease. Am J Obstet Gynecol. 1983 Oct 15;147(4):359-63. doi: 10.1016/s0002-9378(16)32225-6.
- Background: PubMed 1992942Bauer JJ, Sher ME, Jaffin H, Present D, Gelerent I. Transvaginal approach for repair of rectovaginal fistulae complicating Crohn's disease. Ann Surg. 1991 Feb;213(2):151-8. doi: 10.1097/00000658-199102000-00010.
- Background: PubMed 9749498Tsang CB, Madoff RD, Wong WD, Rothenberger DA, Finne CO, Singer D, Lowry AC. Anal sphincter integrity and function influences outcome in rectovaginal fistula repair. Dis Colon Rectum. 1998 Sep;41(9):1141-6. doi: 10.1007/BF02239436.
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, Prof MD principal investigator
General Surgery Department (Hospital Universitario La Paz) and Cell Therapy laboratory
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 Adipose-derived stem cells without expanded in people with Extremely Complex Perianal Fistulae, run by Instituto de Investigación 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 4 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 27 Apr 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 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?
Contact Damián García Olmo, Prof MD (0034 912071022, damian.garcia@uam.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of treatment of extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae (time frame: 16 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 NCT01586715, which also lists 24 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 27 Apr 2012.