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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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Recruitment Status : Withdrawn (company dissolved)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

Tracking Information
First Submitted Date  ICMJE October 3, 2011
First Posted Date  ICMJE October 18, 2011
Last Update Posted Date September 1, 2017
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2011)
  • Clinical improvement in disability score compared to baseline [ Time Frame: 3 months ]
  • 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.
  • Clinical improvement in disability score compared to baseline [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01453764 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2011)
  • MS disease activity measured by the number of Gd-enhancing brain MRI lesions [ Time Frame: 3 months ]
  • Reduced number of relapses or freedom from progression of disease [ Time Frame: 3 months ]
  • Reduced number of relapses or freedom from progression of disease [ Time Frame: 6 months ]
  • MS disease activity measured by the number of Gd-enhancing brain MRI lesions [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into Patients With Multiple Sclerosis
Official Title  ICMJE 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
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?
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis
  • Autoimmune Diseases
  • Autoimmune Diseases of the Nervous System
  • Nervous System Diseases
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Adipose SVF IV Infusion
IV Infusion of Autologous Adipose Derived Stromal Vascular Fraction Intervention: Intravenous Infusion
Intervention: Procedure: Harvesting and Implantation of SVF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 31, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2011)
10
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Mexico
 
Administrative Information
NCT Number  ICMJE NCT01453764
Other Study ID Numbers  ICMJE AD-US-MS-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ageless Regenerative Institute
Study Sponsor  ICMJE Ageless Regenerative Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sharon McQuillan, MD Ageless Regenerative Institute
PRS Account Ageless Regenerative Institute
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP