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

Primary Purpose

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

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Harvesting and Implantation of SVF
Sponsored by
Ageless Regenerative Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ageless Regenerative Institute LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adipose SVF IV Infusion

Arm Description

IV Infusion of Autologous Adipose Derived Stromal Vascular Fraction Intervention: Intravenous Infusion

Outcomes

Primary Outcome Measures

Clinical improvement in disability score compared to baseline
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.
Clinical improvement in disability score compared to baseline

Secondary Outcome Measures

MS disease activity measured by the number of Gd-enhancing brain MRI lesions
Reduced number of relapses or freedom from progression of disease
Reduced number of relapses or freedom from progression of disease
MS disease activity measured by the number of Gd-enhancing brain MRI lesions

Full Information

First Posted
October 3, 2011
Last Updated
August 31, 2017
Sponsor
Ageless Regenerative Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01453764
Brief Title
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into Patients With Multiple Sclerosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
company dissolved
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ageless Regenerative Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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?
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Nervous System Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adipose SVF IV Infusion
Arm Type
Experimental
Arm Description
IV Infusion of Autologous Adipose Derived Stromal Vascular Fraction Intervention: Intravenous Infusion
Intervention Type
Procedure
Intervention Name(s)
Harvesting and Implantation of SVF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical improvement in disability score compared to baseline
Time Frame
3 months
Title
Number of patients with adverse events
Description
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.
Time Frame
up to 6 months
Title
Clinical improvement in disability score compared to baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
MS disease activity measured by the number of Gd-enhancing brain MRI lesions
Time Frame
3 months
Title
Reduced number of relapses or freedom from progression of disease
Time Frame
3 months
Title
Reduced number of relapses or freedom from progression of disease
Time Frame
6 months
Title
MS disease activity measured by the number of Gd-enhancing brain MRI lesions
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon McQuillan, MD
Organizational Affiliation
Ageless Regenerative Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ageless Regenerative Institute LLC
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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