A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT02418351
• Date of registration: 08/04/2015
• Prospective Registration: No
• Primary sponsor: Genesis Limited
• Public title: A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS
• Scientific title: An Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS
• Date of first enrolment: February 2015
• Target sample size: 69
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02418351
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

India, Trinidad and Tobago

Contacts

• Name: Dr. Bill Brashier, M.D
• Affiliation: Genesis Institute of Cellular Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males and Females between age 18 and 60 years

- Diagnosis of Relapsing Remitting Multiple Sclerosis made by a neurology expert/MS
expert with lesions demonstrated on brain MRI that are consistent with MS

- Duration of disease: >5 years

- Having an EDSS (Kurtzke Expanded Disability Status Scale) score between 3.5 & 6

- History of 2 or more relapses within last 2 years with increase in EDSS scale of >
0.5 sustained for > 4 weeks

- Failure to respond or intolerance to the currently available Multiple Sclerosis (MS)
immunomodulatory treatments): the lack of response to these treatments will be
determined/defined by history of 2 or more relapses within last 2 years with increase
in EDSS scale of > 0.5 sustained for > 4 weeks

- Must have proof of health insurance in country of residence

Exclusion Criteria:

- Primary progressive, secondary progressive or progressive relapsing MS as defined by
Lublin and Reingold, 1996. These conditions require the presence of continuous
clinical disease worsening over a period of at least 3 months. Subjects with these
conditions may also have superimposed relapses but are distinguished from relapsing
remitting subjects by the lack of clinically stable periods of clinical improvement.

- Unable to perform Timed 25-Foot Walk, 9 Hole Peg Test (HPT) (with both upper
extremities) and Paced Auditory Serial Addition Test (PASAT 3)

- Females who are pregnant or nursing or females of childbearing potential who are
unwilling to maintain contraceptive therapy for the duration of the study

- Life expectancy < 6 months due to concomitant illnesses

- Exposure to any investigational drug or procedure within 1 month prior to study entry
or enrolled in a concurrent study that may confound results of this study.

- Active infectious disease: For patients who have tested positive, an expert will be
consulted as to patient eligibility based on the patient's infectious status

- Any illness which, in the Investigator's judgment, will interfere with the patient's
ability to comply with the protocol, compromise patient safety, or interfere with the
interpretation of the study results

- Patients on chronic immunosuppressive transplant therapy

- Patients with unstable cardiac status (unstable angina, attack of myocardial
infarction within last 6 months, uncontrolled high blood pressure, hypotension,
cardiomyopathy)

- Cerebrovascular accident within 6 months prior to study entry

- Patients with poorly controlled diabetes mellitus

- Patients with renal insufficiency (Creatinine> 2.5) or failure

- Known drug or alcohol dependence or any other factors which will interfere with the
study conduct or interpretation of the results or who in the opinion of the
investigator is not suitable to participate.

- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in
the last five years

- Unwilling and/or not able to give written informed consent.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Biological: Autologous Bone Marrow-Derived Mononuclear Stem Cells

Other: Liberation therapy

Primary Outcome(s)

Proportion of patients with clinical improvement in EDSS score compared to baseline [Time Frame: Up to 12 months]

Proportion of patients with adverse events [Time Frame: Time Frame: up to 12 months]

Secondary Outcome(s)

Proportion of patients with a change in cognitive function as measured by the Paced Auditory Serial Addition Test (PASAT) [Time Frame: 12 months]

Proportion of patients with a change in either gadolinium enhancing or new T2-weighted lesions on brain MRI [Time Frame: 12 months]

Proportion of patients with clinical improvement in EDSS score compared to baseline [Time Frame: 3 months and 6 months]

Proportion of patients with clinical improvement in MSIS score compared to baseline [Time Frame: 3 months, 6 months and 12 months]

Proportion of patients with a change in upper extremity function as measured by the Nine Hole Peg Test [Time Frame: 12 months]

Proportion of patients with reduction in T2 lesion volume on brain MRI [Time Frame: 12 months]

Proportion of patients with reduction in brain volume on MRI [Time Frame: 12 months]

Proportion of patients with a change in mobility and leg function as measured by the 25 foot walking test [Time Frame: 12 months]

Proportion of patients with reduced number of relapses or freedom from progression of disease [Time Frame: 3 months, 6 months and 12 months]

Secondary ID(s)

PRT/GENESIS/2015/002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors