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

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ClinicalTrials.gov Identifier: NCT01453764
Recruitment Status : Withdrawn (company dissolved)
First Posted : October 18, 2011
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Ageless Regenerative Institute

Brief 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?

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Nervous System Diseases Procedure: Harvesting and Implantation of SVF Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adipose SVF IV Infusion
IV Infusion of Autologous Adipose Derived Stromal Vascular Fraction Intervention: Intravenous Infusion
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.




Primary Outcome Measures :
  1. Clinical improvement in disability score compared to baseline [ Time Frame: 3 months ]
  2. Number of patients with adverse events [ Time Frame: up to 6 months ]
    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.

  3. Clinical improvement in disability score compared to baseline [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. MS disease activity measured by the number of Gd-enhancing brain MRI lesions [ Time Frame: 3 months ]
  2. Reduced number of relapses or freedom from progression of disease [ Time Frame: 3 months ]
  3. Reduced number of relapses or freedom from progression of disease [ Time Frame: 6 months ]
  4. MS disease activity measured by the number of Gd-enhancing brain MRI lesions [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453764


Locations
United States, Florida
Ageless Regenerative Institute LLC
Aventura, Florida, United States, 33180
Sponsors and Collaborators
Ageless Regenerative Institute
Investigators
Principal Investigator: Sharon McQuillan, MD Ageless Regenerative Institute

Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT01453764     History of Changes
Other Study ID Numbers: AD-US-MS-001
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Nervous System Diseases
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases