NCT02326935

Brief Summary

The intent of this clinical study is to answer the questions: 1) is the proposed treatment safe and 2) is treatment effective in improving the disease pathology of patients with Multiple Sclerosis and clinical outcomes.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1 multiple-sclerosis

Timeline
Completed

Started Nov 2014

Typical duration for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2018

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

3.5 years

First QC Date

December 18, 2014

Last Update Submit

May 18, 2018

Conditions

Multiple Sclerosis

Keywords

MSMultiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Chronic ProgressiveMyelitis

Outcome Measures

Primary Outcomes (4)

  • Standard Complication Questionnaire

    incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed

    3 months

  • MS Impact Scale - MSIS-29

    Multiple Sclerosis Impact Scale (MSIS-29)

    3 months

  • Modified SF-36 Cell-Based Therapy Follow Up

    Modified SF-36 for Cell-Based Therapy Follow Up

    3 months

  • Physical Evaluation

    Vital signs of sitting blood pressure, temperature and heart rate

    3 Months

Secondary Outcomes (11)

  • MS Impact Scale - MSIS-29

    6 months

  • MS Impact Scale - MSIS-29

    1 year

  • Modified SF-36 Cell-Based Therapy Follow Up

    6 months

  • Standard Complication Questionnaire

    6 months

  • Standard Complication Questionnaire

    1 year

  • +6 more secondary outcomes

Study Arms (1)

Adipose derived mesenchymal cells

EXPERIMENTAL

Intervention: Autologous adipose derived mesenechymal stem cells, 150 million cells deployed via two (2) treatments via intravenous injection Other Names: ADSC, mesenchymal cells, stromal cells

Biological: Autologous adipose derived mesenchymal cells

Interventions

Autologous adipose derived mesenchymal cellsBIOLOGICAL

Autologous adipose derived mesenchymal cells, 150M cells deployed via two (2) treatments via intravenous injection.

Also known as: ADSC, mesenchymal cells, stromal cells
Adipose derived mesenchymal cells

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed Diagnosis of MS
  • Aged 18 - 65 years.
  • Duration of disease: \>5 years
  • Signed, written informed consent willing and able to comply with study visits according to protocol for the full study period
  • Physically, mentally and legally capable of international travel for treatment

You may not qualify if:

  • 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
  • Patient with any active or chronic infection
  • No life-threatening organ dysfunction.
  • Pregnancy or risk of pregnancy.
  • Severe physical limitations or disabilities
  • Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C
  • Patients unable to give written informed consent in accordance with research ethics board guidelines
  • Treatment with any immunosuppressive therapy within the 3 months prior to randomization
  • Current treatment with an investigational therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Da Vinci Center

George Town, KY1-1205, Cayman Islands

Location

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Chronic ProgressiveMyelitis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System InfectionsInfectionsCentral Nervous System DiseasesSpinal Cord DiseasesNeuroinflammatory Diseases

Study Officials

  • Louis A Cona, MD

    The Da Vinci Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 30, 2014

Study Start

November 1, 2014

Primary Completion

May 18, 2018

Study Completion

May 18, 2018

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

CA(1)