PouchitisPhase 1NCT05578508
Stem Cells for the Treatment of Pouchitis
A Phase 1 study testing Mesenchymal Stem Cells (MSCs) in people with Pouchitis and Crohn's Disease, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and feasibility of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with medically refractory Pouchitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pouchitis, Crohn's Disease, Ulcerative Colitis Chronic
- What is being tested?
- Mesenchymal Stem Cells (MSCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2022to Feb 2024
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18-75 years of age
- Residents of the United States
- Medically refractory pouchitis defined as lack of response to antibiotics, immunomodulators, and/or biologics
- Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF therapy, anti-integrin and anti-interleukin are permitted if have been on them for at least 2 months prior to study enrollment without change
- No malignant or premalignant intestinal condition, ruled out on colonoscopy within 90 days of MSC delivery
- Ability to comply with protocol
- Competent and able to provide written informed consent
- Must have failed or have a contraindication to standard medical therapy including anti-TNF, anti-interleukin, or anti-integrin agent
Who cannot join
- Inability to give informed consent
- Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient
- Specific exclusions:
- HIV
- Hepatitis B or C
- Abnormal CBC at screening
Show all 15Show fewer
- Abnormal AST or ALT at screening
- History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment
- Investigational drug use within thirty (30) days of baseline
- Pregnant or breastfeeding
- Multifocal proximal small bowel involvement which resembles Crohn's of the small bowel
- Evidence of pelvic sepsis and pelvic penetrating fistulizing disease
- Patients with intestinal diversion above the level of the pouch
- Neoplasia of pouch
- Change in medical regimen for pouchitis in the two months prior to study enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Bone Marrow Derived Mesenchymal Stem Cells (MSCs) for the Treatment of Medically Refractory Pouchitis
The purpose of this study is to determine the safety and feasibility of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with medically refractory Pouchitis.
Read the detailed description
Proctocolectomy with ileal pouch anal anastomosis (IPAA) remains the procedure of choice for patients with chronic ulcerative colitis (CUC). IPAA allows at-risk tissue to be removed with restoration of intestinal continuity while maintaining favorable long-term functional outcomes and quality of life.
While less than 30% of patients experience short-term postoperative morbidity following IPAA, up to 15% of pouches will ultimately fail due to technical or inflammatory complications, the majority of which manifest as a fistula from the pouch to the perianal or vaginal locations. After anastomotic leak, the second leading cause of pouch fistulas is the development of Crohn's disease of the pouch. While the majority of pouches are constructed for CUC, up to 25% will end up having a change in diagnosis to CD which manifests as refractor pouchitis, strictures of the proximal small bowel, or most often as peripouch fistulas. Pouch failure due to refractory pouchitis are notoriously difficult to treat, and reconstructive pouch surgery or transanal repairs are often not offered due to suspicion of recurrent pouchitis following pouch reconstruction. The reality is that patients with refractory pouchitis will end up with a major reconstructive transabdominal operation in a select few for attempt at pouch salvage, or, most likely, a permanent end ileostomy after pouch excision. This can be a devastating outcome in some patients as it impacts body image and quality of life.
Similar to refractory pouchitis, Crohn's related perianal and rectovaginal fistula are other phenotypes of inflammatory bowel disease that are also notoriously difficult to treat with conventional medical and surgical options. Despite an ever expanding repertoire of biologic therapy and surgical intervention, sustained healing rates are less than 30%. This has driven investigators to search for alternative approaches, and in 2003 investigators reported successful healing of a refractory Crohn's rectovaginal fistula following injection of mesenchymal stem cells (MSCs). Following this success, several phase I, II, and III trials designed to study the safety and efficacy of MSCs for perianal CD, all of which have reported encouraging results with superior efficacy compared to conventional medical and surgical therapies. Over 300 perianal CD patients have now been treated without increase in adverse events and no risk of incontinence.
Given the high safety profile, and substantial success in treating perianal CD, the investigators are using a GMP grade allogeneic adipose derived MSCs to establish safety and secondarily monitor for healing in patients with medically refractory pouchitis. This trial will use allogeneic bone marrow derived mesenchymal stem cells (MSCs) to produce regenerative signals which alter the ileal pouch microbiome and local inflammatory mileau. Patients with CD of the pouch suffer chronic immunosuppression and surgical intervention and desperately need an improved therapeutic. The research aims to address the root cause of this inflammation, especially the interactions of the intestinal microbiome and host immune response through a novel therapeutic approach. The specific rationale for MSCs in medical refractory pouchitis is based opon 1) their anti-inflammatory properties; 2) published experience of MSC in this condition and perianal Crohn's fistula demonstrating efficacy and safety; 3) existence of cGMP methods for their isolation and growth.
The study will enroll adult patients with medically refractory pouchitis, whose next option in the treatment plan would be major reconstructive abdominal surgery or pouch excision with a permanent end ileostomy.
- Conditions
- Pouchitis, Crohn's Disease, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases, Pouch, Ileal
- Being tested
- Mesenchymal Stem Cells (MSCs)
- Keywords
- Mesenchymal Stem Cells, Crohn's Disease, Inflammatory Bowel Diseases, Pouchitis, Ulcerative Colitis
- Medical subject headings
- Pouchitis, Crohn Disease, Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cells (MSCs)Drug
Also called Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (MSCs)
Endoscopic injection of allogeneic bone marrow derived mesenchymal stem cells (MSCs) to the ileal pouch.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Submucosal endoscopic injection of 60 million allogeneic bone marrow derived mesenchymal stem cells (MSCs) into ileal pouch at baseline and possibly again after 3 months if not completely healed. Receives: Drug: Mesenchymal Stem Cells (MSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of adverse events that occur throughout the study.
Measured: Change from Baseline over 12 months after the MSC injection
Healing
PDAI endoscopic activity less than or equal to 1, Clinical PDAI score less than or equal to 2, and total PDAI less than or equal to 4
Measured: Change from Baseline over 12 months after the MSC Injection
Secondary outcomes (9)
Endoscopic Remission
PDAI endoscopic activity less than or equal to 1 Mayo Endoscopic score less than or equal to 1, defined as the absence of friability or ulceration
Measured: Change from Baseline over 12 months after the MSC Injection
Clinical Remission
Clinical PDAI score less than or equal to 2 MDPAI score less than or equal to 4
Measured: Change from Baseline over 12 months after the MSC Injection
Endoscopic Improvement
Reduction in the endoscopic PDAI score, but still greater than 1 Reduction in the Mayo endoscopic score, but still greater than 1 Reduction in endoscopic MPDAI score by 2 or more points
Measured: Change from Baseline over 12 months after the MSC Injection
Clinical Improvement
Reduction in the clinical PDAI score of 2 or more points Reduction in the Clinical MPDAI score of 2 or more points Decrease in 24-hour stool frequency
Measured: Change from Baseline over 12 months after the MSC Injection
Partial Clinical Healing measured with the Pouchitis Disease Activity Index No No response
No improvement in the PDAI overall, endoscopic, or clinical scores No decrease in Mayo endoscopic severity score No decrease in 24 hour stool frequency
Measured: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months after MSC injection
Partial Clinical Healing
Decrease in C-reactive protein serum levels by greater than 50%
Measured: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months after MSC injection
Partial Clinical Healing
Decreased mucosal ulceration on pouchoscopy
Measured: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months after MSC injection
Partial Clinical Healing
Improved healing on endoscopic biopsy or surgical pathology as compared to pre-MSC delivery endoscopic biopsies.
Measured: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months after MSC injection
Assess for alloimmune response
Measure HLA Class B Antibody Screening
Measured: Baseline, 1 month, 3 month, 12 month after MSC injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study startApr 2022 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Why it stopped: PI decision not to move forward with study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PouchitisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Principal investigator, Anthony Lembo, The Cleveland Clinic
- Investigators
- Amy L Lightner, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578508
- Sponsor's protocol ID
- CCF-Pouchitis
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2019
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 12756590Cho YB, Lee WY, Park KJ, Kim M, Yoo HW, Yu CS. Autologous adipose tissue-derived stem cells for the treatment of Crohn's fistula: a phase I clinical study. Cell Transplant. 2013;22(2):279-85. doi: 10.3727/096368912X656045. Epub 2012 Sep 21.
PubMed 23006344Dietz AB, Dozois EJ, Fletcher JG, Butler GW, Radel D, Lightner AL, Dave M, Friton J, Nair A, Camilleri ET, Dudakovic A, van Wijnen AJ, Faubion WA. Autologous Mesenchymal Stem Cells, Applied in a Bioabsorbable Matrix, for Treatment of Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2017 Jul;153(1):59-62.e2. doi: 10.1053/j.gastro.2017.04.001. Epub 2017 Apr 9.
PubMed 28400193Garcia-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 I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009 Jan;52(1):79-86. doi: 10.1007/DCR.0b013e3181973487.
PubMed 19273960Molendijk I, Bonsing BA, Roelofs H, Peeters KC, Wasser MN, Dijkstra G, van der Woude CJ, Duijvestein M, Veenendaal RA, Zwaginga JJ, Verspaget HW, Fibbe WE, van der Meulen-de Jong AE, Hommes DW. Allogeneic Bone Marrow-Derived Mesenchymal Stromal Cells Promote Healing of Refractory Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2015 Oct;149(4):918-27.e6. doi: 10.1053/j.gastro.2015.06.014. Epub 2015 Jun 25.
PubMed 26116801Cho YB, Park KJ, Yoon SN, Song KH, Kim DS, Jung SH, Kim M, Jeong HY, Yu CS. Long-term results of adipose-derived stem cell therapy for the treatment of Crohn's fistula. Stem Cells Transl Med. 2015 May;4(5):532-7. doi: 10.5966/sctm.2014-0199. Epub 2015 Mar 31.
PubMed 25829404Lee WY, Park KJ, Cho YB, Yoon SN, Song KH, Kim DS, Jung SH, Kim M, Yoo HW, Kim I, Ha H, Yu CS. Autologous adipose tissue-derived stem cells treatment demonstrated favorable and sustainable therapeutic effect for Crohn's fistula. Stem Cells. 2013 Nov;31(11):2575-81. doi: 10.1002/stem.1357.
PubMed 23404825Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial. Lancet. 2016 Sep 24;388(10051):1281-90. doi: 10.1016/S0140-6736(16)31203-X. Epub 2016 Jul 29.
PubMed 27477896Ciccocioppo R, Bernardo ME, Sgarella A, Maccario R, Avanzini MA, Ubezio C, Minelli A, Alvisi C, Vanoli A, Calliada F, Dionigi P, Perotti C, Locatelli F, Corazza GR. Autologous bone marrow-derived mesenchymal stromal cells in the treatment of fistulising Crohn's disease. Gut. 2011 Jun;60(6):788-98. doi: 10.1136/gut.2010.214841. Epub 2011 Jan 21.
PubMed 21257987de la Portilla F, Alba F, Garcia-Olmo D, Herrerias JM, Gonzalez FX, Galindo A. Expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of complex perianal fistula in Crohn's disease: results from a multicenter phase I/IIa clinical trial. Int J Colorectal Dis. 2013 Mar;28(3):313-23. doi: 10.1007/s00384-012-1581-9. Epub 2012 Sep 29.
PubMed 23053677
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Bone Marrow Derived Mesenchymal Stem Cells (MSCs) for the Treatment of Medically Refractory Pouchitis
- ClinicalTrials.gov ID
- NCT05578508
- Acronym / sponsor ID
- CCF-Pouchitis
- Conditions
- Pouchitis, Crohn's Disease, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases, Pouch, Ileal
- Keywords
- Mesenchymal Stem Cells, Crohn's Disease, Inflammatory Bowel Diseases, Pouchitis, Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decision not to move forward with study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- Apr 2022 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 13 Oct 2022 (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.
The purpose of this study is to determine the safety and feasibility of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with medically refractory Pouchitis.
Detailed description
Proctocolectomy with ileal pouch anal anastomosis (IPAA) remains the procedure of choice for patients with chronic ulcerative colitis (CUC). IPAA allows at-risk tissue to be removed with restoration of intestinal continuity while maintaining favorable long-term functional outcomes and quality of life.
While less than 30% of patients experience short-term postoperative morbidity following IPAA, up to 15% of pouches will ultimately fail due to technical or inflammatory complications, the majority of which manifest as a fistula from the pouch to the perianal or vaginal locations. After anastomotic leak, the second leading cause of pouch fistulas is the development of Crohn's disease of the pouch. While the majority of pouches are constructed for CUC, up to 25% will end up having a change in diagnosis to CD which manifests as refractor pouchitis, strictures of the proximal small bowel, or most often as peripouch fistulas. Pouch failure due to refractory pouchitis are notoriously difficult to treat, and reconstructive pouch surgery or transanal repairs are often not offered due to suspicion of recurrent pouchitis following pouch reconstruction. The reality is that patients with refractory pouchitis will end up with a major reconstructive transabdominal operation in a select few for attempt at pouch salvage, or, most likely, a permanent end ileostomy after pouch excision. This can be a devastating outcome in some patients as it impacts body image and quality of life.
Similar to refractory pouchitis, Crohn's related perianal and rectovaginal fistula are other phenotypes of inflammatory bowel disease that are also notoriously difficult to treat with conventional medical and surgical options. Despite an ever expanding repertoire of biologic therapy and surgical intervention, sustained healing rates are less than 30%. This has driven investigators to search for alternative approaches, and in 2003 investigators reported successful healing of a refractory Crohn's rectovaginal fistula following injection of mesenchymal stem cells (MSCs). Following this success, several phase I, II, and III trials designed to study the safety and efficacy of MSCs for perianal CD, all of which have reported encouraging results with superior efficacy compared to conventional medical and surgical therapies. Over 300 perianal CD patients have now been treated without increase in adverse events and no risk of incontinence.
Given the high safety profile, and substantial success in treating perianal CD, the investigators are using a GMP grade allogeneic adipose derived MSCs to establish safety and secondarily monitor for healing in patients with medically refractory pouchitis. This trial will use allogeneic bone marrow derived mesenchymal stem cells (MSCs) to produce regenerative signals which alter the ileal pouch microbiome and local inflammatory mileau. Patients with CD of the pouch suffer chronic immunosuppression and surgical intervention and desperately need an improved therapeutic. The research aims to address the root cause of this inflammation, especially the interactions of the intestinal microbiome and host immune response through a novel therapeutic approach. The specific rationale for MSCs in medical refractory pouchitis is based opon 1) their anti-inflammatory properties; 2) published experience of MSC in this condition and perianal Crohn's fistula demonstrating efficacy and safety; 3) existence of cGMP methods for their isolation and growth.
The study will enroll adult patients with medically refractory pouchitis, whose next option in the treatment plan would be major reconstructive abdominal surgery or pouch excision with a permanent end ileostomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Mesenchymal Stem Cells (MSCs)Submucosal endoscopic injection of 60 million allogeneic bone marrow derived mesenchymal stem cells (MSCs) into ileal pouch at baseline and possibly again after 3 months if not completely healed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women 18-75 years of age
- Residents of the United States
- Medically refractory pouchitis defined as lack of response to antibiotics, immunomodulators, and/or biologics
- Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF therapy, anti-integrin and anti-interleukin are permitted if have been on them for at least 2 months prior to study enrollment without change
- No malignant or premalignant intestinal condition, ruled out on colonoscopy within 90 days of MSC delivery
Key exclusion criteria (15 listed)
- Inability to give informed consent
- Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient
- Specific exclusions:
- History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment
- Investigational drug use within thirty (30) days of baseline
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 Cells (MSCs)Also: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (MSCs)Endoscopic injection of allogeneic bone marrow derived mesenchymal stem cells (MSCs) to the ileal pouch. | Drug | Treatment Arm |
Primary outcome
Adverse Events
Time frame: Change from Baseline over 12 months after the MSC injection
Number of adverse events that occur throughout the study.
Healing
Time frame: Change from Baseline over 12 months after the MSC Injection
PDAI endoscopic activity less than or equal to 1, Clinical PDAI score less than or equal to 2, and total PDAI less than or equal to 4
9 secondary outcomes
Endoscopic Remission
Time frame: Change from Baseline over 12 months after the MSC Injection
Clinical Remission
Time frame: Change from Baseline over 12 months after the MSC Injection
Endoscopic Improvement
Time frame: Change from Baseline over 12 months after the MSC Injection
Clinical Improvement
Time frame: Change from Baseline over 12 months after the MSC Injection
Partial Clinical Healing measured with the Pouchitis Disease Activity Index No No response
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months after MSC injection
Partial Clinical Healing
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months after MSC injection
Partial Clinical Healing
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months after MSC injection
Partial Clinical Healing
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months after MSC injection
Assess for alloimmune response
Time frame: Baseline, 1 month, 3 month, 12 month after MSC injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- 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 23006344Cho YB, Lee WY, Park KJ, Kim M, Yoo HW, Yu CS. Autologous adipose tissue-derived stem cells for the treatment of Crohn's fistula: a phase I clinical study. Cell Transplant. 2013;22(2):279-85. doi: 10.3727/096368912X656045. Epub 2012 Sep 21.
- Background: PubMed 28400193Dietz AB, Dozois EJ, Fletcher JG, Butler GW, Radel D, Lightner AL, Dave M, Friton J, Nair A, Camilleri ET, Dudakovic A, van Wijnen AJ, Faubion WA. Autologous Mesenchymal Stem Cells, Applied in a Bioabsorbable Matrix, for Treatment of Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2017 Jul;153(1):59-62.e2. doi: 10.1053/j.gastro.2017.04.001. Epub 2017 Apr 9.
- 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 19273960Garcia-Olmo D, Herreros D, Pascual I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009 Jan;52(1):79-86. doi: 10.1007/DCR.0b013e3181973487.
- Background: PubMed 26116801Molendijk I, Bonsing BA, Roelofs H, Peeters KC, Wasser MN, Dijkstra G, van der Woude CJ, Duijvestein M, Veenendaal RA, Zwaginga JJ, Verspaget HW, Fibbe WE, van der Meulen-de Jong AE, Hommes DW. Allogeneic Bone Marrow-Derived Mesenchymal Stromal Cells Promote Healing of Refractory Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2015 Oct;149(4):918-27.e6. doi: 10.1053/j.gastro.2015.06.014. Epub 2015 Jun 25.
- Background: PubMed 25829404Cho YB, Park KJ, Yoon SN, Song KH, Kim DS, Jung SH, Kim M, Jeong HY, Yu CS. Long-term results of adipose-derived stem cell therapy for the treatment of Crohn's fistula. Stem Cells Transl Med. 2015 May;4(5):532-7. doi: 10.5966/sctm.2014-0199. Epub 2015 Mar 31.
- Background: PubMed 23404825Lee WY, Park KJ, Cho YB, Yoon SN, Song KH, Kim DS, Jung SH, Kim M, Yoo HW, Kim I, Ha H, Yu CS. Autologous adipose tissue-derived stem cells treatment demonstrated favorable and sustainable therapeutic effect for Crohn's fistula. Stem Cells. 2013 Nov;31(11):2575-81. doi: 10.1002/stem.1357.
- Background: PubMed 27477896Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial. Lancet. 2016 Sep 24;388(10051):1281-90. doi: 10.1016/S0140-6736(16)31203-X. Epub 2016 Jul 29.
- Background: PubMed 21257987Ciccocioppo R, Bernardo ME, Sgarella A, Maccario R, Avanzini MA, Ubezio C, Minelli A, Alvisi C, Vanoli A, Calliada F, Dionigi P, Perotti C, Locatelli F, Corazza GR. Autologous bone marrow-derived mesenchymal stromal cells in the treatment of fistulising Crohn's disease. Gut. 2011 Jun;60(6):788-98. doi: 10.1136/gut.2010.214841. Epub 2011 Jan 21.
- Background: PubMed 23053677de la Portilla F, Alba F, Garcia-Olmo D, Herrerias JM, Gonzalez FX, Galindo A. Expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of complex perianal fistula in Crohn's disease: results from a multicenter phase I/IIa clinical trial. Int J Colorectal Dis. 2013 Mar;28(3):313-23. doi: 10.1007/s00384-012-1581-9. Epub 2012 Sep 29.
- Individual participant dataSharing planned: No
Related trials for Pouchitis
Active, not recruitingPhase 4
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
Pouchitis, Pouches, Ileoanal
RecruitingPhase 4
Rifaximin for the Secondary Prevention of Recurrent Pouchitis
Pouchitis
Not yet recruitingEarly Phase 1
Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC)
Pouchitis, UC - Ulcerative Colitis
RecruitingPhase 2
Etrasimod as Prevention of Pouchitis
Pouchitis
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
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.
Amy L Lightner, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal Stem Cells (MSCs) in people with Pouchitis and Crohn's Disease, run by The Cleveland Clinic at 1 site in United States.
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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 16 Apr 2026. 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 United States. 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 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Adverse Events (time frame: Change from Baseline over 12 months after the MSC injection). The study lists 2 primary outcomes in all. 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 NCT05578508, which also lists 11 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 16 Apr 2026.