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

NCT ID: NCT02326935

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-05-18

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Autologous adipose derived mesenchymal cells

Intervention Type: BIOLOGICAL

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

Interventions

Autologous adipose derived mesenchymal cells

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

Intervention Type: BIOLOGICAL

Other Intervention Names

ADSC, mesenchymal cells, stromal cells

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American CryoStem Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis A Cona, MD

Role: PRINCIPAL_INVESTIGATOR

The Da Vinci Center

Locations

The Da Vinci Center

George Town, , Cayman Islands

Countries

Cayman Islands

Other Identifiers

CRYO-MS-ADSC-006

Identifier Type: -

Identifier Source: org_study_id