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WithdrawnNCT01453764Updated Sep 1, 2017

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

An interventional study of Harvesting and Implantation of SVF in Multiple Sclerosis, Autoimmune Diseases and Autoimmune Diseases of the Nervous System, sponsored by Ageless Regenerative Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Ageless Regenerative Institute · Not applicable, Interventional, and Treatment

Why this study was withdrawn
company dissolved
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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?
Read the 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.

02

Conditions studied

  • Multiple Sclerosis
  • Autoimmune Diseases
  • Autoimmune Diseases of the Nervous System
  • Nervous System Diseases
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Adipose SVF IV Infusion

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

    Procedure: Harvesting and Implantation of SVF

Interventions

  • ProcedureHarvesting 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.

05

What researchers measure

Primary outcomes

  1. Clinical improvement in disability score compared to baseline

    Time frame: 3 months

  2. 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.

    Time frame: up to 6 months

  3. Clinical improvement in disability score compared to baseline

    Time frame: 6 months

Secondary outcomes

  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

06

Study locations

1 site
  • Ageless Regenerative Institute LLC
    Aventura, Florida 33180, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT01453764
Lead sponsor
Ageless Regenerative Institute
Responsible party
Sponsor
First posted
Oct 18, 2011
Start date
Apr 2016
Primary completion
Dec 2018 (estimated)
Completion
Apr 2019 (estimated)
Last update
Sep 1, 2017

Study contacts

Sharon McQuillan, MD
principal investigator · Ageless Regenerative Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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