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

Phase 1

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Biological: Autologous adipose derived mesenchymal cells

• Registration Number: NCT02326935
• Lead Sponsor: American CryoStem Corporation

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-30
• Status Verified: 2018-05
• Primary Completion: 2018-05-18
• Study Completion: 2018-05-18
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adipose derived mesenchymal cells	Autologous 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

Primary Outcome Measures

Name	Time	Method
Standard Complication Questionnaire	3 months	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	3 months	Multiple Sclerosis Impact Scale (MSIS-29)
Physical Evaluation	3 Months	Vital signs of sitting blood pressure, temperature and heart rate
Modified SF-36 Cell-Based Therapy Follow Up	3 months	Modified SF-36 for Cell-Based Therapy Follow Up

Secondary Outcome Measures

Name	Time	Method
MS Impact Scale - MSIS-29	1 year	Multiple Sclerosis Impact Scale (MSIS-29)
Modified SF-36 Cell-Based Therapy Follow Up	6 months	Modified SF-36 for Cell-Based Therapy Follow Up
Standard Complication Questionnaire	5 years	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	1 Year	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

Trial Locations

Locations (1)

The Da Vinci Center; 🇰🇾 George Town, Cayman Islands