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 Cleveland Clinic1 site in 1 country24 target enrollmentMarch 2011

ConditionsRelapsing-Remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis Progressive Relapsing Multiple Sclerosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsing-Remitting Multiple Sclerosis
Sponsor: The Cleveland Clinic
Enrollment: 24
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

May 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The Cleveland Clinic

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

To evaluate effects on MS disease activity measured by the number of Gd-enhancing brain MRI lesions(1 month)
To evaluate safety and tolerability of autologous MSC transplantation over 6 months(6 months)