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A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Terminated
Phase
Phase 1
Locations
Trinidad and Tobago
Study Type
Interventional
Intervention
Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells
Liberation therapy
Sponsored by
Genesis Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring RRMS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Main inclusion criteria: Males and Females between age 18 and 60 years with confirmed diagnosis of Relapsing Remitting Multiple Sclerosis made by a neurology expert/MS expert with lesions demonstrated on brain MRI that are consistent with MS and having an EDSS (Kurtzke Expanded Disability Status Scale) score between 3.5 & 6

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.

Sites / Locations

  • Genesis Institute of Cellular Medicine, Genesis (Trinidad and Tobago) Private Limited

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AllogeneicHumanUmbilicalCordTissue-DerivedMesenchymalStemCells

Arm Description

Super selective intravenous administration of 50 million Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and intrathecal administration of UC-MSCs in dose of 100 million along with liberation therapy (when associated with CCSVI)

Outcomes

Primary Outcome Measures

Proportion of patients with clinical improvement in EDSS score compared to baseline
Proportion of patients with clinical improvement in EDSS score compared to baseline (Time Frame: 12 months). Clinical improvement is defined as decrease in Expanded Disability Status Scale (EDSS) score greater than 0.5 from baseline.

Secondary Outcome Measures

Proportion of patients with a change in either gadolinium enhancing or new T2-weighted lesions on brain MRI
Proportion of patients with reduction in T2 lesion volume on brain MRI
Proportion of patients with reduction in brain volume on MRI
Proportion of patients with clinical improvement in EDSS score compared to baseline
Proportion of patients with clinical improvement in MSIS score compared to baseline
Proportion of patients with clinical improvement in MSFC score compared to baseline
Proportion of patients with a change in mobility and leg function as measured by the 25 foot walking test
Proportion of patients with a change in upper extremity function as measured by the Nine Hole Peg Test
Proportion of patients with a change in cognitive function as measured by the Paced Auditory Serial Addition Test (PASAT)
Proportion of patients with reduced number of relapses or freedom from progression of disease

Full Information

First Posted
April 8, 2015
Last Updated
November 3, 2015
Sponsor
Genesis Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02418325
Brief Title
A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS
Official Title
An Open-label, Non-randomized, Phase I/II Study of Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and Liberation Therapy (When Associated With Chronic Cerebrovascular Venous Insufficiency) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genesis Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
STUDY OBJECTIVES: Primary Objective: Assessment of treatment safety based on incidence of any treatment emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months post treatment. Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3 months, 6 months and 12 months after treatment based on the following: EDSS and 29-item Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1) Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and gadolinium-enhanced magnetic resonance imaging (MRI)
Detailed Description
STUDY TREATMENT: Investigational therapy product: Wharton Jelly derived allogeneic MSCs. Method of administration and dose: Super selective intravenous administration of 50 million Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and intrathecal administration of UC-MSCs in dose of 100 million along with liberation therapy (when associated with CCSVI). SAFETY AND EFFICACY EVALUATION: The proposed study will assess safety and primary and secondary efficacy endpoints after super selective intravenous and intrathecal administration of allogeneic umbilical cord mesenchymal stem cells (UC-MSC) in 69 patients with Relapsing Remitting Multiple Sclerosis. Safety Evaluation: Assessment of treatment safety based on incidence of any treatment emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months post treatment. Efficacy evaluation: Clinical evaluations, including EDSS and 29-item Multiple Sclerosis Impact Scale (MSIS-29) will be performed at baseline before stem cell mobilization, prior to discharge at 1, 3, 6 and 12 months after stem cell therapy. The MS Functional Composite (MSFC) consists of the (a) Timed 25-Foot Walk, (b) 9 Hole Peg Test, and (c) Paced Auditory Serial Addition Test will be performed at baseline before stem cell mobilization and at 12 months after stem cell therapy. Gadolinium enhanced MRI scans of the brain will be performed at baseline before therapy and then 12 months after stem cell therapy. Follow-up scans will be performed on the same type of scanner used at baseline. Scans will be analyzed centrally. The 'baseline MRI scan' will be the reference for brain volume changes. DATA COLLECTION AND STATISTICAL ANALYSIS: Descriptive analyses of the adverse events will be performed. Proportion of adverse events at each visit will be calculated using frequency distribution. The frequency, severity, timing and the potential relationship to the intervention will be assessed in order to characterize the safety of the intervention. The probability of overall event-free survival (as well as progression-free, relapse-free, or MRI event-free survival) at baseline through 1 year will be calculated. The end point of progression is defined as increased Expanded Disability Status Scale (EDSS) score greater than 0.5 from baseline. Analyses will be conducted using Kaplan-Meier estimates with Wald-type 90% CIs based on Greenwood's formula for SE. Descriptive analyses of all primary and secondary efficacy endpoints will be performed using descriptive statistics. Proportion of patients with clinically significant change in this efficacy measurement scales (EDSS, MSIS, MSFC, MSFC-25 foot walking test, MSFC-Nine Hole Peg Test, MSFC-Paced Auditory Serial Addition Test) and change in gadolinium enhancing lesions, new T2 lesions from previous visit will be presented as a proportion. The percentage of change in brain volume will be calculated from screening and analyzed by end point status at month 12 with an exact Wilcoxon rank sum test using mean scores when the results are identical.The null hypothesis tests whether the median percentage of change in brain volume among participants who met the endpoint by month 12 is equal to the median of those who have not met the end point by month 12. Other primary and secondary efficacy endpoints (EDSS, MSIS, MSFC, MSFC-25 foot walking test, MSFC-Nine Hole Peg Test, MSFC-Paced Auditory Serial Addition Test) will be analyzed using a Wilcoxon signed rank test. Change from baseline outcomes for all the endpoints will be calculated for each patient who underwent stem cell transplant as the post transplant value minus the baseline value. The null hypothesis tests whether the median difference from baseline measurement in the values at the month 1, month 3, month 6 and month 12 visits was significantly different from zero,with baseline measurement defined as the screening assessment for the percentage of change in brain volume and the baseline visit for all other end points. To calculate MSFC, results from each of the 3 components will be transformed into a z score and averaged to yield a composite for each patient at each timepoint. The z scores that compose the MSFC score will be calculated using the reference population from the National Multiple Sclerosis Society Task Force database.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
RRMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AllogeneicHumanUmbilicalCordTissue-DerivedMesenchymalStemCells
Arm Type
Experimental
Arm Description
Super selective intravenous administration of 50 million Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and intrathecal administration of UC-MSCs in dose of 100 million along with liberation therapy (when associated with CCSVI)
Intervention Type
Biological
Intervention Name(s)
Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells
Intervention Description
Super selective intravenous administration of 50 million Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and intrathecal administration of UC-MSCs in dose of 100 million along with liberation therapy (when associated with CCSVI)
Intervention Type
Other
Intervention Name(s)
Liberation therapy
Primary Outcome Measure Information:
Title
Proportion of patients with clinical improvement in EDSS score compared to baseline
Description
Proportion of patients with clinical improvement in EDSS score compared to baseline (Time Frame: 12 months). Clinical improvement is defined as decrease in Expanded Disability Status Scale (EDSS) score greater than 0.5 from baseline.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Proportion of patients with a change in either gadolinium enhancing or new T2-weighted lesions on brain MRI
Time Frame
12 months
Title
Proportion of patients with reduction in T2 lesion volume on brain MRI
Time Frame
12 months
Title
Proportion of patients with reduction in brain volume on MRI
Time Frame
12 months
Title
Proportion of patients with clinical improvement in EDSS score compared to baseline
Time Frame
3 months and 6 months
Title
Proportion of patients with clinical improvement in MSIS score compared to baseline
Time Frame
3 months, 6 months and 12 months
Title
Proportion of patients with clinical improvement in MSFC score compared to baseline
Time Frame
3 months, 6 months and 12 months
Title
Proportion of patients with a change in mobility and leg function as measured by the 25 foot walking test
Time Frame
12 months
Title
Proportion of patients with a change in upper extremity function as measured by the Nine Hole Peg Test
Time Frame
12 months
Title
Proportion of patients with a change in cognitive function as measured by the Paced Auditory Serial Addition Test (PASAT)
Time Frame
12 months
Title
Proportion of patients with reduced number of relapses or freedom from progression of disease
Time Frame
3 months, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main inclusion criteria: Males and Females between age 18 and 60 years with confirmed diagnosis of Relapsing Remitting Multiple Sclerosis made by a neurology expert/MS expert with lesions demonstrated on brain MRI that are consistent with MS and having an EDSS (Kurtzke Expanded Disability Status Scale) score between 3.5 & 6 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Bill Brashier, M.D
Organizational Affiliation
Genesis Institute of Cellular Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesis Institute of Cellular Medicine, Genesis (Trinidad and Tobago) Private Limited
City
San Fernando
State/Province
Trinidad
Country
Trinidad and Tobago

12. IPD Sharing Statement

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Learn more about this trial

A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS

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