Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into Patients With Multiple Sclerosis

Ageless Regenerative Institute

Status

Withdrawn

Conditions

Autoimmune Diseases of the Nervous System

Multiple Sclerosis

Nervous System Diseases

Autoimmune Diseases

Treatments

Procedure: Harvesting and Implantation of SVF

Study type

Interventional

Funder types

Industry

Identifiers

NCT01453764

AD-US-MS-001

Details and patient eligibility

About

The intent of this clinical study is to answer the questions:

Is the proposed treatment safe
Is treatment effective in improving the disease pathology of patients with Multiple Sclerosis and clinical outcomes?

Full description

This will be an open-label, non-randomized multi-center patient sponsored study of Adipose-Derived Stromal Cells (ASC) implantation performed intrathecally and intravenously. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and Females between Age 18 and 80 years.
Duration of disease: >5 years
Failure to respond or intolerance to the currently available Multiple Sclerosis (MS) immunomodulatory treatments (ie interferons, Copaxone, immunosuppression): the lack of response to these treatments will be determined/defined by either an increase (deterioration) of at least one degree in the Expanded Disability Status Scale (EDSS) score during the last year or the appearance of at least two major relapses of MS during the same period of time (under treatment) or intolerance to these agents.
Up to date on all age and gender appropriate cancer screening per American Cancer Society .

Exclusion criteria

Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
Life expectancy < 6 months due to concomitant illnesses.
Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
Active infectious disease. For patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status
Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
Patients on chronic immunosuppressive transplant therapy
Systolic blood pressure (supine) ≤90 mmHg;
Resting heart rate > 100 bpm;
Active clinical infection.
Cerebrovascular accident within 6 months prior to study entry
Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
Unwilling and/or not able to give written informed consent.