Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
This study is not yet open for participant recruitment.
Verified by The Cleveland Clinic, January 2009
Sponsors and Collaborators: The Cleveland Clinic
University Hospital Case Medical Center
Information provided by: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00813969
  Purpose

The study is an investigator-run, open-label Phase 1 safety study of autologous mesenchymal stem cell transplantation, involving approximately 24 participants with relapsing forms of MS (approximately equal numbers with relapsing-remitting and secondary progressive/ progressive relapsing MS) and evidence of involvement of the anterior afferent visual system.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Progressive Relapsing Multiple Sclerosis
Biological: Autologous mesenchymal stem cell transplantation
Phase I

MedlinePlus related topics: Multiple Sclerosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety Study
Official Title: A Phase I Study to Assess the Feasibility, Safety, and Tolerability of Autologous Mesenchymal Stem Cell Transplantation in Patients With Relapsing Forms of Multiple Sclerosis

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • To evaluate infusion-related safety and tolerability of autologous MSC transplantation [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate effects on MS disease activity measured by the number of Gd-enhancing brain MRI lesions [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Autologous mesenchymal stem cell transplantation
    A single IV infusion of up to 2 million cells per kg based on the MSC numbers achieved after culture expansion
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 55, inclusive.
  • Diagnosis of MS, as defined by Macdonald and revised by Polman and Swanton
  • Relapsing form of MS (relapsing-remitting, secondary progressive, or progressive-relapsing) course).
  • EDSS score 0-6.5, inclusive.
  • Documented evidence of involvement of the anterior afferent visual system with RNFL thickness on OCT <LLN in at least one eye.
  • Cranial MRI scan demonstrating T2-hyperintense lesions satisfying diagnostic criteria for MS as proposed by Barkhof and modified by Tintore
  • Ability to perform the component tests of the MSFC (T25FW, 9HPT, PASAT3).
  • Ability to perform SLCLA.
  • Has given written informed consent to participate in the study.

Exclusion Criteria:

  • A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days of the Screening Visit.
  • History of cancer other than basal cell carcinoma of the skin.
  • History or laboratory results indicative of any significant cardiac, endocrine, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neoplastic, or other disorder that in the opinion of the Principal Investigator would preclude the safe performance of BM aspiration, infusion of autologous MSCs, or performance of any of the planned study assessments.
  • Abnormal blood tests which exceed designated limits.
  • Positive screening tests for hepatitis B, hepatitis C, HIV 1&2, HTLV I/II, CMV, West Nile virus, syphilis, blood parasite infection.
  • Clinically significant abnormality on chest X-ray.
  • Clinically significant abnormality on EKG.
  • Oxygen-saturation <90% on room air.
  • History of alcohol or drug abuse within one year.
  • Any metallic material or electronic device in the body, or condition that precludes the participant from undergoing MRI with Gd administration.
  • Uncontrolled glaucoma or other ocular condition that precludes performing OCT or interpreting the results.
  • MS relapse with onset within 30 days prior to the Screening Visit or the participant has not stabilized from a previous relapse at the time of the Screening Visit.
  • Current treatment with an investigational MS disease therapy.
  • Prior treatment with:

Total lymphoid irradiation. Cladribine. T-cell or T-cell receptor vaccination. Campath-1h (alemtuzumab). Rituxan (rituximab).

  • Prior treatment within three months with:

Tysabri (natalizumab). Zenapax (daclizumab). Cytoxan (cyclophosphamide). Novantrone (mitoxantrone). Cyclosporine. CellCept (mycophenolate mofetil). Imuran (azathioprine). Rheumatrex (methotrexate). IV gamma globulin. Plasma exchange.

  • Prior treatment within one month:

Systemic corticosteroids with daily dose equivalent to Prednisone 60 mg or greater.

  • Female participants who are not post-menopausal for at least one year, not surgically sterile, or not willing to practice effective contraception.
  • Nursing mothers, pregnant women, or women planning to become pregnant during the study.
  • Male participants who are not willing to practice effective contraception.
  • Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that, in the opinion of the Principal Investigator, is likely to affect the participant's ability to comply with the study protocol.
  • Any other reason that, in the opinion of the Principal Investigator, makes the participant unsuitable for participation in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813969

Locations
United States, Ohio
Cleveland Clinic Mellen Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
University Hospital Case Medical Center
Investigators
Principal Investigator: Jeffrey A Cohen, M.D. Cleveland Clinic
  More Information

Responsible Party: Cleveland Clinic, Mellen Center ( Jeffrey Alan Cohen, M.D. )
Study ID Numbers: MS-MSC-001
Study First Received: December 22, 2008
Last Updated: January 7, 2009
ClinicalTrials.gov Identifier: NCT00813969  
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
Mesenchymal Stem Cell
MSC
Autologous
Multiple Sclerosis

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Neoplasm Metastasis
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System
Multiple Sclerosis, Chronic Progressive

Additional relevant MeSH terms:
Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009