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Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00813969
Recruitment Status : Completed
First Posted : December 23, 2008
Last Update Posted : March 30, 2016
Sponsor:
Collaborator:
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE December 22, 2008
First Posted Date  ICMJE December 23, 2008
Last Update Posted Date March 30, 2016
Study Start Date  ICMJE March 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2011)
To evaluate the feasibility of culturing MSCs, and infusion-related safety and tolerability of autologous MSC transplantation over one month in patients with relapsing forms of MS [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2008)
To evaluate infusion-related safety and tolerability of autologous MSC transplantation [ Time Frame: 1 month ]
Change History Complete list of historical versions of study NCT00813969 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2011)
  • To evaluate effects on MS disease activity measured by the number of Gd-enhancing brain MRI lesions [ Time Frame: 1 month ]
  • To evaluate safety and tolerability of autologous MSC transplantation over 6 months [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2008)
To evaluate effects on MS disease activity measured by the number of Gd-enhancing brain MRI lesions [ Time Frame: 1 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
Official Title  ICMJE 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
Brief Summary The study is an investigator-run, open-label Phase 1 safety study of autologous mesenchymal stem cell transplantation, involving approximately 24 ambulatory 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Relapsing-Remitting Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis
  • Progressive Relapsing Multiple Sclerosis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Autologous MSC transplantation
Intervention: Biological: Autologous mesenchymal stem cell transplantation
Publications * Cohen JA, Imrey PB, Planchon SM, Bermel RA, Fisher E, Fox RJ, Bar-Or A, Sharp SL, Skaramagas TT, Jagodnik P, Karafa M, Morrison S, Reese Koc J, Gerson SL, Lazarus HM. Pilot trial of intravenous autologous culture-expanded mesenchymal stem cell transplantation in multiple sclerosis. Mult Scler. 2018 Apr;24(4):501-511. doi: 10.1177/1352458517703802. Epub 2017 Apr 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2008)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 55, inclusive.
  • Diagnosis of MS
  • Relapsing form of MS (relapsing-remitting, secondary progressive, or progressive-relapsing course).
  • EDSS score 3.0-6.5, inclusive. (Must be able to walk)
  • Active disease during prior 24 months.
  • Documented evidence of involvement of the anterior afferent visual system: previous optic neuritis, optic atrophy or an afferent pupillary defect on exam, RNFL thickness on OCT <LLN in at least one eye OR documented VEP latency in at least 1 eye.
  • Cranial MRI scan demonstrating T2-hyperintense lesions satisfying diagnostic criteria for MS
  • 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). Gilenya (Fingolimod/FTY720). 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00813969
Other Study ID Numbers  ICMJE MS-MSC-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE University Hospitals Cleveland Medical Center
Investigators  ICMJE
Principal Investigator: Jeffrey A Cohen, M.D. The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date March 2016

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