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Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells for the Induction of Remission in Ulcerative Colitis

NCT ID: NCT01914887

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

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The aims of our study are to evaluate the feasibility and safety of endoscopic injection of adipose tissue-derived mesenchymal stem cells in human subjects with moderate active ulcerative colitis, assessing the absence of adverse events associated to the investigational drug, and to evaluate the efficacy of the treatment to induce remission of moderate active ulcerative colitis, by improvements in disease activity index, quality of life index, and endoscopic index.

Detailed Description

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Mesenchymal stem cells (MSC) may be a therapeutic option in diseases associated with severe inflammation or auto-immune diseases, due to their immunomodulatory and anti-inflammatory properties. A number of clinical trials are being conducted worldwide testing th efficacy of MSC, mainly isolated from bone marrow, for different conditions, such as Graft Versus host Disease, refractory Crohn's Disease, ischemic stroke, acute myocardial infarction, type I Diabetes Mellitus, or Chronic Obstructive Pulmonary Disease. Usually, the route of administration of the cells in these studies is intravenous. Local injection of MSC for fistulizing Crohn's Disease has proven efficacious. Endoscopy is a routinary technique for the evaluation of gastrointestinal and colonic conditions. The purpose of our study is to evaluate safety and efficacy of the intracolonic injection by using a colonoscope of allogeneic adipose tissue-derived MSC in patients with moderate active ulcerative colitis.

Conditions

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Ulcerative Colitis

Keywords

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Ulcerative Colitis Inflammatory Bowel Disease Mesenchymal stem cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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allogeneic ASCs

Treatment consists in a cell suspension (5 million cells/mL) in aseptic buffered solution containing human expanded adipose-derived stem cells (eASCs) of allogeneic origin in disposable vials with no preservative agents. The cells will be given in different sites within the affected colonic submucosa at a total dose of 60 million cells with the use of a colonoscope.

Group Type EXPERIMENTAL

Allogeneic adipose tissue-derived mesenchymal stem cells

Intervention Type DRUG

The cells will be given in different sites within the affected colonic submucosa at a total dose of 60 million cells with the use of a colonoscope.

Interventions

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Allogeneic adipose tissue-derived mesenchymal stem cells

The cells will be given in different sites within the affected colonic submucosa at a total dose of 60 million cells with the use of a colonoscope.

Intervention Type DRUG

Other Intervention Names

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Cx-601 (company code)

Eligibility Criteria

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Inclusion Criteria

* Patients of either sex aged 18 years and older
* Signed informed consent
* Patients with ulcerative colitis diagnosed at least 6 months earlier in accordance with usual criteria
* Left-sided colitis with moderate activity defined by a modified Truelove-Witts score between 11 and 21, and with no response to 4 weeks of treatment with oral and/or topical 5-aminosalicylates
* Negative pregnancy test for women of childbearing potential (from menarche to menopause) using consistently and correctly highly effective (i.e. less than 1% failure rate per year) methods of birth control

Exclusion Criteria

* Mental disability that impedes adequate understanding of the study and of the associated procedures
* Extensive colitis
* Patients with an impaired general state which requires, according to the investigator judgment, immediate treatment with corticosteroids and/or anti-Tumor Necrosis Factor (TNF) and/or surgery
* Patients that fulfill criteria of corticodependency and in ongoing treatment with corticosteroids
* Patients with previous colectomies
* Known history of alcohol or other addictive substances abuse
* History of malignant disease - Patients having participated in clinical trials with any investigational drug within 6 months prior to enrolment in this study
* Patients with known allergies to penicillin, gentamicin, aminoglycosides, human serum albumin (HSA), Dulbecco's modified Eagle medium (DMEM), or materials of bovine origin
* Pregnant or breastfeeding women
* Presence of severe concomitant diseases
* Patients with suspicion of Crohn?s enterocolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, or microscopic colitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

OTHER

Sponsor Role collaborator

Ministry of Health, Spain

OTHER_GOV

Sponsor Role collaborator

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Dolores Martin Arranz, MD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology Department

Locations

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Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Maria Dolores Martin Arranz, MD

Role: CONTACT

Phone: +34 917277467

Email: [email protected]

Fernando de Miguel, PhD

Role: CONTACT

Phone: +34 917277389

Email: [email protected]

Facility Contacts

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Maria Dolores Martin Arranz, MD

Role: primary

Fernando de Miguel, PhD

Role: backup

References

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Garcia-Gomez I, Elvira G, Zapata AG, Lamana ML, Ramirez M, Castro JG, Arranz MG, Vicente A, Bueren J, Garcia-Olmo D. Mesenchymal stem cells: biological properties and clinical applications. Expert Opin Biol Ther. 2010 Oct;10(10):1453-68. doi: 10.1517/14712598.2010.519333.

Reference Type BACKGROUND
PMID: 20831449 (View on PubMed)

Duijvestein M, Vos AC, Roelofs H, Wildenberg ME, Wendrich BB, Verspaget HW, Kooy-Winkelaar EM, Koning F, Zwaginga JJ, Fidder HH, Verhaar AP, Fibbe WE, van den Brink GR, Hommes DW. Autologous bone marrow-derived mesenchymal stromal cell treatment for refractory luminal Crohn's disease: results of a phase I study. Gut. 2010 Dec;59(12):1662-9. doi: 10.1136/gut.2010.215152. Epub 2010 Oct 4.

Reference Type BACKGROUND
PMID: 20921206 (View on PubMed)

van Deen WK, Oikonomopoulos A, Hommes DW. Stem cell therapy in inflammatory bowel disease: which, when and how? Curr Opin Gastroenterol. 2013 Jul;29(4):384-90. doi: 10.1097/MOG.0b013e328361f763.

Reference Type BACKGROUND
PMID: 23666365 (View on PubMed)

Other Identifiers

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2010-023798-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HLPDIG-2010-01

Identifier Type: -

Identifier Source: org_study_id