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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02326935
• Other study ID #: CRYO-MS-ADSC-006
• Status: Terminated
• Phase: Phase 1
• Start date: November 2014
• Est. completion date: May 18, 2018

Study information

• Verified date: May 2018
• Source: American CryoStem Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 18, 2018
• Est. primary completion date: May 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Cayman Islands	The Da Vinci Center	George Town

Sponsors (1)

Lead Sponsor	Collaborator
American CryoStem Corporation

Country where clinical trial is conducted

Cayman Islands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	MS Impact Scale - MSIS-29	Multiple Sclerosis Impact Scale (MSIS-29)	3 months
Primary	Modified SF-36 Cell-Based Therapy Follow Up	Modified SF-36 for Cell-Based Therapy Follow Up	3 months
Primary	Physical Evaluation	Vital signs of sitting blood pressure, temperature and heart rate	3 Months
Secondary	MS Impact Scale - MSIS-29	Multiple Sclerosis Impact Scale (MSIS-29)	6 months
Secondary	MS Impact Scale - MSIS-29	Multiple Sclerosis Impact Scale (MSIS-29)	1 year
Secondary	Modified SF-36 Cell-Based Therapy Follow Up	Modified SF-36 for Cell-Based Therapy Follow Up	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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