Clinical Efficacy of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02166021
• Date of registration: 20/05/2014
• Prospective Registration: Yes
• Primary sponsor: Dimitrios Karussis
• Public title: Clinical Efficacy of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple Sclerosis
• Scientific title: Phase 2 Trial to Investigate the Clinical Efficacy & the Optimal Administration (Based on the Immunological, Clinical & Neuroradiological Effects) of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple Sclerosis
• Date of first enrolment: January 29, 2015
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02166021
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Israel

Contacts

• Name: Hadas Lemberg, PhD
• Affiliation: Director, R&D Division

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Consenting patients fulfilling the Poser's clinical criteria for definite MS

2. Age: 18-65, males and females

3. Duration of disease: >3 years

4. Progressive form of MS: PPMS, SPMS (with/without relapses)

5. EDSS score of 3.5 - 6.5

6. Failure to currently available, registered - first and second line immunomodulatory
treatments (at least one).

7. Evidence for new activity of MS during the 3 months before the injection of MSC.

Exclusion Criteria:

1. Patients who were treated with cytotoxic medications during the last 3 months prior to
the inclusion.

2. Patients suffering from significant cardiac, renal or hepatic failure or any other
disease that may risk the patient or interfere with the ability to interpret the
results

3. Patients with active infections

4. Patients with severe cognitive decline or inability to understand and sign the
informed consent

5. Patients who received any cellular treatment in the past



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis (MS)

Intervention(s)

Biological: Mesenchymal stem cells

Primary Outcome(s)

Safety Assessment [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

Neurological efficacy [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

Secondary Outcome(s)

Functional scores [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

EDSS score [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

Immunology [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

Paced Auditory Serial Addition Test (PASAT) [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

Optical coherence tomography (OCT) [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

Total brain volume in MRI [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

25-feet timed walking [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

9-hole peg test [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

Ambulation score [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

Single injection vs. repeated MSCs injection [Time Frame: 12 months: ie the total duration of the trial]

T2-weighted flair lesions load in MRI [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

Relapse rate [Time Frame: 12 months: ie the total duration of the trial]

Cognitive function: Controlled Oral Word Association Test (COWAT) [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

Functional MRI [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

Gadolinium enhancing lesions in MRI [Time Frame: 6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group]

Secondary ID(s)

MSC-MS-001-IL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors