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Clinical Trials/IRCT20191004044975N1
IRCT20191004044975N1
Recruiting
Phase 2

Evaluation of safety and efficacy of Intravenous and Interatechal injection of autologous bone marrow-drived mesenchymal stem cells in RRMS patients under fingolimod therapy: randomized clinical trial with control group, Phase 2 and 3.

Vice-presidency for science and technology0 sites120 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Vice-presidency for science and technology
Enrollment
120
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Vice-presidency for science and technology

Eligibility Criteria

Inclusion Criteria

  • •Clinical diagnosis of RRMS.
  • •EDSS less than 6
  • •Patients who have used the first line of DMD for one year and who have had a clinical attack or deteriorating brain and Cervical Spinal Cord MRI findings in the one past\-year.
  • •Disease progression or the onset of re\-attack or deteriorating MRI findings within the one past\- year prior to inclusion
  • •Normal macula.
  • •Patients' written consent to participate in the study.

Exclusion Criteria

  • •Proven clinical attack 30 days prior to the patient's entry into the study.
  • •Use of corticosteroid drug (MePDN) 30 days prior to the patient's entry into the study.
  • •Having infectious diseases.
  • •A history of another underlying disease Including neoplasm.
  • •The presence of clear disorders in consciousness and cognition.
  • •Creatinine greater than 1\.7 mg/dl Or Liver enzymes three times the upper limit of the normal range or more, Or a white blood cell count less than 3,000/mm3 and hemoglobin less than 10\.7 g/dL.
  • •Treatment with cytotoxic drugs 6 months before starting the study.
  • •Positive laboratory tests for hepatitis B, C, HIV , HTLV, JCV, or syphilis.
  • •The presence of any contain metallic particles implant in the body, due to the limitations in performing the MRI
  • •Positive TB (PPD) test.

Outcomes

Primary Outcomes

Not specified

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