Status:
COMPLETED
Safety and Efficacy of Intravenous Autologous Mesenchymal Stem Cells for MS: a Phase 2 Proof of Concept Study
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The mechanism of action of MSC relies on their ability to modulate pathogenic immune responses and provide neuroprotection through the release of anti-apoptotic, anti-oxidant and trophic factors as de...
Detailed Description
The mechanism of action of Mesenchymal Stem Cells (MSCs) relies on their ability to modulate pathogenic immune responses and provide neuroprotection through the release of anti-apoptotic, anti-oxidant...
Eligibility Criteria
Inclusion
- 1\) Males and females with a diagnosis of MS
- Relapsing remitting MS (RRMS) not responding to at least 1 year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod, dimethyl fumarate, teriflunomide, alemtuzumab) as evidenced by at least one of the following:
- i) ≥1 clinically documented relapse in past 12 months
- ii) ≥2 clinically documented relapses in past 24 months
- iii) ≥1 gadolinium-enhancing lesion (GEL) at MRI performed within the past 12 months
- Secondary progressive MS (SPMS) not responding to at least a year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod, dimethylfumarate, teriflunomide, alemtuzumab) as evidenced by both:
- i) an increase of ≥1 EDSS point (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥ 5.5) in the past 12 months
- ii) ≥1 clinically documented relapse or ≥ 1 gadolinium-enhancing lesion (GEL) at MRI within the past 12 months
- Primary progressive MS (PPMS) patients with all the following features:
- i) an increase of ≥1 EDSS point (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥5.5), in the past 12 months
- ii) ≥ 1 gadolinium-enhancing lesion (GEL) at MRI performed within the past 12 months
- iii) positive cerebrospinal fluid (CSF) (oligoclonal banding)
- 2\) Age 18 to 50 years old, inclusive at time of informed consent
- 3\) Disease duration 2 to 15 years (inclusive)
- 4\) EDSS 2.5 to 6.5
- 5\) Able and willing to sign informed consent prior to any study-related activities
Exclusion
- 1\) RRMS not fulfilling inclusion criteria
- 2\) SPMS not fulfilling inclusion criteria
- 3\) PPMS not fulfilling inclusion criteria
- 4\) A history of active or chronic infection including infection with HIV1-2, chronic Hepatitis B or Hepatitis C
- 5\) Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
- 6\) Previous treatment with cladribine or alemtuzumab
- 7\) Treatment with interferon-beta, glatiramer acetate, teriflunomide or dimethyl fumarate within the 30 days prior to randomization (all teriflunomide patients will be required to have followed a wash-out with either cholestyramine or activated charcoal as indicated in the product monograph)
- 8\) Treatment with corticosteroids within the 30 days prior to randomization
- 9\) Relapse occurred during the 60 days prior to randomization
- 10\) Previous history of a malignancy (patient reported) other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year
- 11\) Severely limited life expectancy by any other co-morbid illness
- 12\) History of previous diagnosis of myelodysplasia or previous hematologic disease (patient reported) or current clinically relevant abnormalities of white blood cell counts
- 13\) Pregnancy or risk of pregnancy (this includes participants that are not willing to practice active contraception for the duration of the study)
- 14\) eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination
- 15\) Known allergy to gentamicin or related aminoglycosides
- 16\) Inability to give written informed consent in accordance with research ethics board guidelines
- 17\) Concomitant participation in another clinical trial
- 18\) Inability to adhere to protocol according to the investigator's medical judgement
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02239393
Start Date
June 1 2015
End Date
December 1 2019
Last Update
March 4 2020
Active Locations (2)
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1
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
2
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6