Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Hospital Case Medical Center
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00813969
First received: December 22, 2008
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Progressive Relapsing Multiple Sclerosis
Biological: Autologous mesenchymal stem cell transplantation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 ] [ 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 ]
  • To evaluate safety and tolerability of autologous MSC transplantation over 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: March 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous MSC transplantation 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
  • 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.
  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. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00813969     History of Changes
Other Study ID Numbers: MS-MSC-001
Study First Received: December 22, 2008
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014