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

Multiple Sclerosis Clinical Trial

Official title:

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously Into Patients With Multiple Sclerosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01453764
• Other study ID #: AD-US-MS-001
• Status: Withdrawn
• Phase: N/A
• First received: October 3, 2011
• Last updated: August 31, 2017
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: August 2017
• Source: Ageless Regenerative Institute
• 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

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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Autoimmune Diseases of the Nervous System
• Multiple Sclerosis
• Nervous System Diseases
• Sclerosis

Intervention

Procedure:
• Harvesting and Implantation of SVF
The cell therapy in this study is composed of stem cells derived from a patient's own adipose tissue that are harvested by liposuction using tumescent technique and isolated in the laboratory. The Adipose SVF will be delivered via intravenous injection.

Locations

Country	Name	City	State
United States	Ageless Regenerative Institute LLC	Aventura	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ageless Regenerative Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement in disability score compared to baseline		3 months
Primary	Number of patients with adverse events	The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.	up to 6 months
Primary	Clinical improvement in disability score compared to baseline		6 months
Secondary	MS disease activity measured by the number of Gd-enhancing brain MRI lesions		3 months
Secondary	Reduced number of relapses or freedom from progression of disease		3 months
Secondary	Reduced number of relapses or freedom from progression of disease		6 months
Secondary	MS disease activity measured by the number of Gd-enhancing brain MRI lesions		6 months