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Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in Multiple Sclerosis

U

University of Jordan

Status and phase

Completed
Phase 2
Phase 1

Conditions

Multiple Sclerosis

Treatments

Biological: Autologous Mesenchymal Stem Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT01895439
MSUJCTC

Details and patient eligibility

About

  1. Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice using xenogenic free media instead of the previously used FCS.
  2. Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment.
  3. Assessing the therapeutic benefits on the participants in the trial as per established methods.

Enrollment

13 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A clinical diagnosis of definite MS according to the revised McDonald Criteria.
  • Expanded Disability Status Scale (EDSS) ≤ 6
  • Failure of standard medical therapy
  • Disease duration of at least three years prior to enrollment.

Exclusion criteria

  • Pregnant and lactating women
  • Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment
  • Recent MS relapse in the month prior to enrollment
  • Treatment with oral or parenteral steroids for any cause in the month prior to enrollment
  • Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders
  • Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment
  • Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast.
  • Positive serology for HIV, Hepatitis B or Hepatitis C
  • Any history of malignancy or exposure to radiation at any time prior to enrollment
  • Any contra-indication to lumbar puncture
  • Severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

MSCs injection
Experimental group
Description:
Autologous bone marrow derived stem cells injected intrathecally to enrolled MS patients
Treatment:
Biological: Autologous Mesenchymal Stem Cells

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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