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Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
This study is not yet open for participant recruitment.
Study NCT00813969   Information provided by The Cleveland Clinic
First Received: December 22, 2008   Last Updated: April 15, 2009   History of Changes

December 22, 2008
April 15, 2009
June 2009
December 2013   (final data collection date for primary outcome measure)
To evaluate infusion-related safety and tolerability of autologous MSC transplantation [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00813969 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
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

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.

 
Phase I
Interventional
Treatment, Open Label, Single Group Assignment, Safety Study
  • Relapsing-Remitting Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis
  • Progressive Relapsing Multiple Sclerosis
Biological: Autologous mesenchymal stem cell transplantation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
24
 
December 2013   (final data collection date for primary outcome measure)

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 3.0-6.5, inclusive.
  • Active disease during prior 24 months.
  • 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.
Both
18 Years to 55 Years
No
 
United States
 
NCT00813969
Jeffrey Alan Cohen, M.D., Cleveland Clinic, Mellen Center
MS-MSC-001
The Cleveland Clinic
University Hospital Case Medical Center
Principal Investigator: Jeffrey A Cohen, M.D. Cleveland Clinic
The Cleveland Clinic
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP