Crohn DiseasePhase 1/2NCT01157650
Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From Adipose Tissue
A Phase 1/2 study testing Autologous mesenchymal stem cells in people with Crohn Disease, run by Clinica Universidad de Navarra, Universidad de Navarra at 3 sites in Spain.
Trial summary
Primary outcome measure: Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred during the study. Secondary outcome measures: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Autologous mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesSpain
- Study dates
- Jun 2010to Sep 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fistulizing Crohn´s disease patients with 1 or more enterocutaneous fistulas, recto-vaginal fistula or complex perianal fistula. The complex perianal fistula is defined as a fistula presenting one of these conditions:
- Trans-sphincteric, supra-sphincteric or extra-sphincteric tract, determined with:
- Clinical criteria: No palpation of the tract and surgical exploration
- Radiological criteria: Nucleal Magnetic Resonance (NMR)or Echoendoscopy
- Multiple fistulas
- "Horseshoe" fistula
Show all 15Show fewer
- Any fistula with fecal incontinence associated
- Any fistula with a risk of fecal incontinence as a result of:
- previous anal fistula surgery or other perianal pathology (hemorrhoids, fissures), that involves lesions or muscular complications.
- Obstetric or iatrogenic sphincter lesions
- Patients with Crohn Disease (CD) at screening and been diagnosed within 12 months before acceptance of clinical, endoscopical, anatomopathological and/or radiological criteria and have a non-active CD.(Crohn´s Disease Activity Index (CDAI)≤ 200)
- > 18 Years and both genders eligible.
- Negative pregnancy test In female fertile subjects
- Patient must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care.
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements
Who cannot join
- Patients with a highly active CD, i.e., if they meet any of the following criteria:
- Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active luminal disease that requires immediate treatment, revealed by rectosigmoidoscopy
- CDAI ≥201
- Presence of abscess or other collections not drained (revealed by basal radiologic study).
- Presence of setons drainage, unless they are removed before treatment beginning.
- Rectal and/ or anal stenosis revealed with rectoscopy or EBA.
Show all 20Show fewer
- Patients needs surgery in the perianal region for other reasons than fistulas at inclusion or within 26 weeks after treatment administration.
- Patients who have received infliximab or any other anti-TNF agent within 8 weeks before the cell treatment administration.
- Patients who have received tacrolimus or cyclosporine within 4 weeks before cell treatment.
- Patients with a history of alcohol or other addictive substances abuse within 6 months before inclusion.
- Severe uncontrolled diseases (chronic renal failure, cardio, pulmonary,…).
- Any type of medical or psychiatric disease which are considered as exclusion criteria, in the investigator's opinion.
- Patients with diagnosis of malignant neoplasia, except basal cell or epidermoid carcinoma of the skin or previous history of malignant tumours, except those that have no evidence of relapse for at least 5 years.
- Subjects with congenital or acquired immunodeficiency.
- Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
- Patient had major surgery or serious traumatism within 6 weeks before enrolment.
- Pregnant or breast-feeding women.
- Physical or psychical impossibility of following the protocol requirements
- Patients who are receiving or received other investigational drugs within 30 days prior to basal visit.
- Impossibility of doing an radiological exploration (reaction to contrast material, pacemakers, claustrophobia,…)
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Clínica Universitaria de Navarra
Pamplona, Pamplona, 31008
Hospital Provincial de Navarra
Pamplona, Pamplona, 31008
Hospital Virgen del Camino
Pamplona, Pamplona, 31008
About this study
Primary outcome measure:
Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred during the study.
Read more
Secondary outcome measures:
- Evaluating the Adipose-derived mesenchymal stem cells therapeutic effect, in particular:
- Fistulas healing efficiency
- Changes in quality of life in patients treated
- Changes of systemic Crohn's disease after implant
- Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem Cells treatment success.
- Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with:
- Phenotype study
- Suppressor capacity study.
- Citoquines production analysis
Read the detailed description
The aim of this study is to evaluate the role of Autologous Mesechymal Stem Cells derived from adipose tissue in the treatment of fistulous Crohn disease.
15 Crohn's disease patients with one or more enterocutaneous, recto-vaginal or complex perianal fistula, will be included.
The trial is divided in three phases:
- - Selection: Patients evaluation for study eligibility will take place within two weeks after Informed Consent signature.
Fistulous disease will be evaluated by MRI for perianal and rectovaginal fistulas, and by CT scan in the case of enterocutaneous fistula.
Previous laboratory test and radiological studies are valid for evaluation if they were obtained within two and six months, respectively, prior to this evaluation, and in the absence of clinical changes.
II.- Treatment phase includes:
- Liposuction procedure to obtain adipose tissue.
- Processing and production of Autologous Mesenchymal Stem Cells from adipose tissue (ASCs)
- ASCs implant
III.- Follow up: Study visits post-implant will take place at the 1st week (+/- 3 days), 4th week (+/- 3 days), 8th week (+/- 7 days), 12nd week (+/- 7 days), 24th week (+/- 7 days), and 1 year (+/- 7 days) after implant.
- Conditions
- Crohn Disease
- Being tested
- Autologous mesenchymal stem cells
- Keywords
- Fistulizing Crohn's disease, stem cells implant
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous mesenchymal stem cellsOther
Also called Implant of ASCs.
The trial is divided in three phases:
- - Selection: Patients evaluation for study eligibility will take place within two weeks after Informed Consent signature.
II.- Treatment phase includes:
- Liposuction procedure to obtain adipose tissue.
- Processing and production of Autologous Mesenchymal Stem Cells from adipose tissue (ASCs)
- ASCs implant
III.- Follow up: Study visits post-implant will take place at the 1st week (+/- 3 days), 4th week (+/- 3 days), 8th week (+/- 7 days), 12nd week (+/- 7 days), 24th week (+/- 7 days), and 1 year (+/- 7 days) after implant.
| Study group | Role | What they receive |
|---|---|---|
| Autologous mesenchymal stem cells | Experimental | Fistulizing Crohn's disease Receives: Other: Autologous mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Security and tolerance
Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Chron's disease patients, collecting the reactions and adverse events occurred during the study
Measured: 3 years
Secondary outcomes (1)
therapeutic effect
- Evaluting the ASCs therapeutic effect, in particular:
- Fistulas healing efficiency
- Changes in quality of life in patients treated
- Changes of systemic Crohn's disease after implant
- Relapse rate monitored among patients who achieved ASCs treatment success.
- Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with:
- Phenotype study
- Suppressor capacity study.
- Citoquines production analysis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felipe Prosper, MD, PhD, Study director, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157650
- Sponsor's protocol ID
- CSM/CROH
- Other IDs
- 2009-009880-71, 2009
- Status last verified
- Nov 2016
- First submitted
- 5 Jul 2010
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nivatvongs S, Gordon PH. Crohn's Disease. In: Gordon PH, Nivatvongs S, editors. Principles and practice of surgery for the colon rectum and anus Third ed. New York: Informa Healthcare; 2007. p. 819-908.
Brullet E, Bonfill X, Urrutia G, Ruiz Ochoa V, Cueto M, Clofent J, Martinez Salmeron JF, Riera J, Obrador A. [Epidemiological study on the incidence of inflammatory bowel disease in 4 Spanish areas. Spanish Group on the Epidemiological Study of Inflammatory Bowel Disease]. Med Clin (Barc). 1998 May 16;110(17):651-6. Spanish.
PubMed 9656209Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. doi: 10.1053/gast.2002.32362.
PubMed 11910338Arin Letamendia A, Borda Celaya F, Burusco Paternain MJ, Prieto Martinez C, Martinez Echeverria A, Elizalde Apestegui I, Laiglesia Izquierdo M, Macias Mendizabal E, Tamburri Moso P, Sanchez Valverde F. [High incidence rates of inflammatory bowel disease in Navarra (Spain). Results of a prospective, population-based study]. Gastroenterol Hepatol. 2008 Mar;31(3):111-6. doi: 10.1157/13116497. Spanish.
PubMed 18341841Lapidus A, Bernell O, Hellers G, Lofberg R. Clinical course of colorectal Crohn's disease: a 35-year follow-up study of 507 patients. Gastroenterology. 1998 Jun;114(6):1151-60. doi: 10.1016/s0016-5085(98)70420-2.
PubMed 9609751Parsi MA, Lashner BA, Achkar JP, Connor JT, Brzezinski A. Type of fistula determines response to infliximab in patients with fistulous Crohn's disease. Am J Gastroenterol. 2004 Mar;99(3):445-9. doi: 10.1111/j.1572-0241.2004.04083.x.
PubMed 15056083Michelassi F, Stella M, Balestracci T, Giuliante F, Marogna P, Block GE. Incidence, diagnosis, and treatment of enteric and colorectal fistulae in patients with Crohn's disease. Ann Surg. 1993 Nov;218(5):660-6. doi: 10.1097/00000658-199321850-00012.
PubMed 8239781Gardiner KR, Dasari BV. Operative management of small bowel Crohn's disease. Surg Clin North Am. 2007 Jun;87(3):587-610. doi: 10.1016/j.suc.2007.03.011.
PubMed 17560414Hyder SA, Travis SP, Jewell DP, McC Mortensen NJ, George BD. Fistulating anal Crohn's disease: results of combined surgical and infliximab treatment. Dis Colon Rectum. 2006 Dec;49(12):1837-41. doi: 10.1007/s10350-006-0656-5.
PubMed 17041753Gelbmann CM, Rogler G, Gross V, Gierend M, Bregenzer N, Andus T, Scholmerich J. Prior bowel resections, perianal disease, and a high initial Crohn's disease activity index are associated with corticosteroid resistance in active Crohn's disease. Am J Gastroenterol. 2002 Jun;97(6):1438-45. doi: 10.1111/j.1572-0241.2002.05685.x.
PubMed 12094862Pearson DC, May GR, Fick GH, Sutherland LR. Azathioprine and 6-mercaptopurine in Crohn disease. A meta-analysis. Ann Intern Med. 1995 Jul 15;123(2):132-42. doi: 10.7326/0003-4819-123-2-199507150-00009.
PubMed 7778826Lecomte T, Contou JF, Beaugerie L, Carbonnel F, Cattan S, Gendre JP, Cosnes J. Predictive factors of response of perianal Crohn's disease to azathioprine or 6-mercaptopurine. Dis Colon Rectum. 2003 Nov;46(11):1469-75. doi: 10.1007/s10350-004-6795-7.
PubMed 14605564Sandborn WJ, Present DH, Isaacs KL, Wolf DC, Greenberg E, Hanauer SB, Feagan BG, Mayer L, Johnson T, Galanko J, Martin C, Sandler RS. Tacrolimus for the treatment of fistulas in patients with Crohn's disease: a randomized, placebo-controlled trial. Gastroenterology. 2003 Aug;125(2):380-8. doi: 10.1016/s0016-5085(03)00877-1.
PubMed 12891539Present DH, Lichtiger S. Efficacy of cyclosporine in treatment of fistula of Crohn's disease. Dig Dis Sci. 1994 Feb;39(2):374-80. doi: 10.1007/BF02090211.
PubMed 8313821Hanauer SB, Smith MB. Rapid closure of Crohn's disease fistulas with continuous intravenous cyclosporin A. Am J Gastroenterol. 1993 May;88(5):646-9.
PubMed 8480725
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From Adipose Tissue
- ClinicalTrials.gov ID
- NCT01157650
- Acronym / sponsor ID
- CSM/CROH
- Conditions
- Crohn Disease
- Keywords
- Fistulizing Crohn's disease, stem cells implant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Jul 2010 (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.
Primary outcome measure:
Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred during the study.
Secondary outcome measures:
- Evaluating the Adipose-derived mesenchymal stem cells therapeutic effect, in particular:
- Fistulas healing efficiency
- Changes in quality of life in patients treated
- Changes of systemic Crohn's disease after implant
- Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem Cells treatment success.
- Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with:
- Phenotype study
- Suppressor capacity study.
- Citoquines production analysis
Detailed description
The aim of this study is to evaluate the role of Autologous Mesechymal Stem Cells derived from adipose tissue in the treatment of fistulous Crohn disease.
15 Crohn's disease patients with one or more enterocutaneous, recto-vaginal or complex perianal fistula, will be included.
The trial is divided in three phases:
- - Selection: Patients evaluation for study eligibility will take place within two weeks after Informed Consent signature.
Fistulous disease will be evaluated by MRI for perianal and rectovaginal fistulas, and by CT scan in the case of enterocutaneous fistula.
Previous laboratory test and radiological studies are valid for evaluation if they were obtained within two and six months, respectively, prior to this evaluation, and in the absence of clinical changes.
II.- Treatment phase includes:
- Liposuction procedure to obtain adipose tissue.
- Processing and production of Autologous Mesenchymal Stem Cells from adipose tissue (ASCs)
- ASCs implant
III.- Follow up: Study visits post-implant will take place at the 1st week (+/- 3 days), 4th week (+/- 3 days), 8th week (+/- 7 days), 12nd week (+/- 7 days), 24th week (+/- 7 days), and 1 year (+/- 7 days) after implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous mesenchymal stem cells | Experimental | Other: Autologous mesenchymal stem cellsFistulizing Crohn's disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Fistulizing Crohn´s disease patients with 1 or more enterocutaneous fistulas, recto-vaginal fistula or complex perianal fistula. The complex perianal fistula is defined as a fistula presenting one of these conditions:
- Patients with Crohn Disease (CD) at screening and been diagnosed within 12 months before acceptance of clinical, endoscopical, anatomopathological and/or radiological criteria and have a non-active CD.(Crohn´s Disease Activity Index (CDAI)≤ 200)
- > 18 Years and both genders eligible.
- Negative pregnancy test In female fertile subjects
- Patient must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care.
Key exclusion criteria (20 listed)
- Patients with a highly active CD, i.e., if they meet any of the following criteria:
- Presence of abscess or other collections not drained (revealed by basal radiologic study).
- Presence of setons drainage, unless they are removed before treatment beginning.
- Rectal and/ or anal stenosis revealed with rectoscopy or EBA.
- Patients needs surgery in the perianal region for other reasons than fistulas at inclusion or within 26 weeks after 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 |
|---|---|---|
| Autologous mesenchymal stem cellsAlso: Implant of ASCs.The trial is divided in three phases: I. - Selection: Patients evaluation for study eligibility will take place within two weeks after Informed Consent signature. II.- Treatment phase includes: 1. Liposuction procedure to obtain adipose tissue. 2. Processing and production of Autologous Mesenchymal Stem Cells from adipose tissue (ASCs) 3. ASCs implant III.- Follow up: Study visits post-implant will take place at the 1st week (+/- 3 days), 4th week (+/- 3 days), 8th week (+/- 7 days), 12nd week (+/- 7 days), 24th week (+/- 7 days), and 1 year (+/- 7 days) after implant. | Other | Autologous mesenchymal stem cells |
Primary outcome
Security and tolerance
Time frame: 3 years
Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Chron's disease patients, collecting the reactions and adverse events occurred during the study
1 secondary outcome
therapeutic effect
Time frame: 3 years
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 8 Nov 2016.
- BackgroundNivatvongs S, Gordon PH. Crohn's Disease. In: Gordon PH, Nivatvongs S, editors. Principles and practice of surgery for the colon rectum and anus Third ed. New York: Informa Healthcare; 2007. p. 819-908.
- Background: PubMed 9656209Brullet E, Bonfill X, Urrutia G, Ruiz Ochoa V, Cueto M, Clofent J, Martinez Salmeron JF, Riera J, Obrador A. [Epidemiological study on the incidence of inflammatory bowel disease in 4 Spanish areas. Spanish Group on the Epidemiological Study of Inflammatory Bowel Disease]. Med Clin (Barc). 1998 May 16;110(17):651-6. Spanish.
- Background: PubMed 11910338Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. doi: 10.1053/gast.2002.32362.
- Background: PubMed 18341841Arin Letamendia A, Borda Celaya F, Burusco Paternain MJ, Prieto Martinez C, Martinez Echeverria A, Elizalde Apestegui I, Laiglesia Izquierdo M, Macias Mendizabal E, Tamburri Moso P, Sanchez Valverde F. [High incidence rates of inflammatory bowel disease in Navarra (Spain). Results of a prospective, population-based study]. Gastroenterol Hepatol. 2008 Mar;31(3):111-6. doi: 10.1157/13116497. Spanish.
- Background: PubMed 9609751Lapidus A, Bernell O, Hellers G, Lofberg R. Clinical course of colorectal Crohn's disease: a 35-year follow-up study of 507 patients. Gastroenterology. 1998 Jun;114(6):1151-60. doi: 10.1016/s0016-5085(98)70420-2.
- Background: PubMed 15056083Parsi MA, Lashner BA, Achkar JP, Connor JT, Brzezinski A. Type of fistula determines response to infliximab in patients with fistulous Crohn's disease. Am J Gastroenterol. 2004 Mar;99(3):445-9. doi: 10.1111/j.1572-0241.2004.04083.x.
- Background: PubMed 8239781Michelassi F, Stella M, Balestracci T, Giuliante F, Marogna P, Block GE. Incidence, diagnosis, and treatment of enteric and colorectal fistulae in patients with Crohn's disease. Ann Surg. 1993 Nov;218(5):660-6. doi: 10.1097/00000658-199321850-00012.
- Background: PubMed 17560414Gardiner KR, Dasari BV. Operative management of small bowel Crohn's disease. Surg Clin North Am. 2007 Jun;87(3):587-610. doi: 10.1016/j.suc.2007.03.011.
- Background: PubMed 17041753Hyder SA, Travis SP, Jewell DP, McC Mortensen NJ, George BD. Fistulating anal Crohn's disease: results of combined surgical and infliximab treatment. Dis Colon Rectum. 2006 Dec;49(12):1837-41. doi: 10.1007/s10350-006-0656-5.
- Background: PubMed 12094862Gelbmann CM, Rogler G, Gross V, Gierend M, Bregenzer N, Andus T, Scholmerich J. Prior bowel resections, perianal disease, and a high initial Crohn's disease activity index are associated with corticosteroid resistance in active Crohn's disease. Am J Gastroenterol. 2002 Jun;97(6):1438-45. doi: 10.1111/j.1572-0241.2002.05685.x.
- Background: PubMed 7778826Pearson DC, May GR, Fick GH, Sutherland LR. Azathioprine and 6-mercaptopurine in Crohn disease. A meta-analysis. Ann Intern Med. 1995 Jul 15;123(2):132-42. doi: 10.7326/0003-4819-123-2-199507150-00009.
- Background: PubMed 14605564Lecomte T, Contou JF, Beaugerie L, Carbonnel F, Cattan S, Gendre JP, Cosnes J. Predictive factors of response of perianal Crohn's disease to azathioprine or 6-mercaptopurine. Dis Colon Rectum. 2003 Nov;46(11):1469-75. doi: 10.1007/s10350-004-6795-7.
- 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.
Felipe Prosper, MD, PhD study director
Clinica Universidad de Navarra
3 sites 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 Autologous mesenchymal stem cells in people with Crohn Disease, run by Clinica Universidad de Navarra, Universidad de Navarra at 3 sites 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 15 inclusion and 20 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Security and tolerance (time frame: 3 years). 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 NCT01157650, which also lists 21 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 8 Nov 2016.