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

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

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Biological: Autologous adipose derived mesenchymal cells

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• Cayman Islands
  • George Town, Cayman Islands, KY1-1205
    • The Da Vinci Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adipose derived mesenchymal cells; 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; Autologous adipose derived mesenchymal cells, 150M cells deployed via two (2) treatments via intravenous injection.; Other Names: ADSC, mesenchymal cells, stromal cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MS Impact Scale - MSIS-29	Multiple Sclerosis Impact Scale (MSIS-29)	6 months
MS Impact Scale - MSIS-29	Multiple Sclerosis Impact Scale (MSIS-29)	1 year
Modified SF-36 Cell-Based Therapy Follow Up	Modified SF-36 for Cell-Based Therapy Follow Up	6 months
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	6 months
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	1 year
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	2 years
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 years
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	4 years
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	5 years
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	6 months
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	1 Year

Collaborators and Investigators

• Sponsor: American CryoStem Corporation
• Investigators: Principal Investigator: Louis A Cona, MD, The Da Vinci Center

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 18, 2018
• Study Completion (Actual): May 18, 2018

Study Registration Dates

• First Submitted: December 18, 2014
• First Submitted That Met QC Criteria: December 23, 2014
• First Posted (Estimate): December 30, 2014

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: MS; Multiple Sclerosis, Relapsing-Remitting; Myelitis; Multiple Sclerosis, Chronic Progressive
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CRYO-MS-ADSC-006