search
Back to results

Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Phase 1
Locations
Cayman Islands
Study Type
Interventional
Intervention
Autologous adipose derived mesenchymal cells
Sponsored by
American CryoStem Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MS, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Myelitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Da Vinci Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adipose derived mesenchymal cells

Arm Description

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

Outcomes

Primary Outcome Measures

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
MS Impact Scale - MSIS-29
Multiple Sclerosis Impact Scale (MSIS-29)
Modified SF-36 Cell-Based Therapy Follow Up
Modified SF-36 for Cell-Based Therapy Follow Up
Physical Evaluation
Vital signs of sitting blood pressure, temperature and heart rate

Secondary Outcome Measures

MS Impact Scale - MSIS-29
Multiple Sclerosis Impact Scale (MSIS-29)
MS Impact Scale - MSIS-29
Multiple Sclerosis Impact Scale (MSIS-29)
Modified SF-36 Cell-Based Therapy Follow Up
Modified SF-36 for Cell-Based Therapy Follow Up
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
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
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
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
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
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
Physical Evaluation
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
Physical Evaluation
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

Full Information

First Posted
December 18, 2014
Last Updated
May 18, 2018
Sponsor
American CryoStem Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT02326935
Brief Title
Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple Sclerosis
Official Title
Proposal for a Non-randomized, Patient Sponsored, Multi-center Study Studying the Impact and Safety of the Utilization of Culture Expanded Autologous, Adipose-derived Mesenchymal Stem Cells Deployed Via Intravenous Injection for the Treatment of Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 18, 2018 (Actual)
Study Completion Date
May 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American CryoStem Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This will be an open-label, non-randomized multi-center patient sponsored study of ADSC implantation using an IV delivery system. The study will provide therapies to up to 100 qualified patients who match the inclusion/exclusion criteria, agree to the follow up program and who have provided a signed consent for each procedure. The treatment is a combination of (a) general detoxification, (b) lymphatic massage/drainage, (c) therapeutic massage, reflexology and acupuncture and (d) cellular infusion therapy in which cells will be deployed via IV injection over two treatments of 60 minutes each during the five (5) day treatment period. Follow-up data based upon MSIS-29, a modified SF-36 and standard complication questionnaire will be collected at 3, 6 and then annually post treatment by the patients' local physician and reported back to the sponsor where it will be logged into a HIPPA-compliant outcomes database. Additional safety data, based upon a standard complication questionnaire will be collected via survey of patient at intervals of 3 and 6 months and then annually for a minimum of five (5) years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
MS, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Myelitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Adipose derived mesenchymal cells
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Autologous adipose derived mesenchymal cells
Other Intervention Name(s)
ADSC, mesenchymal cells, stromal cells
Intervention Description
Autologous adipose derived mesenchymal cells, 150M cells deployed via two (2) treatments via intravenous injection.
Primary Outcome Measure Information:
Title
Standard Complication Questionnaire
Description
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
Time Frame
3 months
Title
MS Impact Scale - MSIS-29
Description
Multiple Sclerosis Impact Scale (MSIS-29)
Time Frame
3 months
Title
Modified SF-36 Cell-Based Therapy Follow Up
Description
Modified SF-36 for Cell-Based Therapy Follow Up
Time Frame
3 months
Title
Physical Evaluation
Description
Vital signs of sitting blood pressure, temperature and heart rate
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
MS Impact Scale - MSIS-29
Description
Multiple Sclerosis Impact Scale (MSIS-29)
Time Frame
6 months
Title
MS Impact Scale - MSIS-29
Description
Multiple Sclerosis Impact Scale (MSIS-29)
Time Frame
1 year
Title
Modified SF-36 Cell-Based Therapy Follow Up
Description
Modified SF-36 for Cell-Based Therapy Follow Up
Time Frame
6 months
Title
Standard Complication Questionnaire
Description
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
Time Frame
6 months
Title
Standard Complication Questionnaire
Description
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
Time Frame
1 year
Title
Standard Complication Questionnaire
Description
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
Time Frame
2 years
Title
Standard Complication Questionnaire
Description
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
Time Frame
3 years
Title
Standard Complication Questionnaire
Description
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
Time Frame
4 years
Title
Standard Complication Questionnaire
Description
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
Time Frame
5 years
Title
Physical Evaluation
Description
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
Time Frame
6 months
Title
Physical Evaluation
Description
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
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis A Cona, MD
Organizational Affiliation
The Da Vinci Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Da Vinci Center
City
George Town
ZIP/Postal Code
KY1-1205
Country
Cayman Islands

12. IPD Sharing Statement

Learn more about this trial

Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple Sclerosis

We'll reach out to this number within 24 hrs