Multiple SclerosisNCT01453764
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into Patients With Multiple Sclerosis
A study testing Harvesting and Implantation of SVF in people with Multiple Sclerosis and Autoimmune Diseases, run by Ageless Regenerative Institute at 1 site in United States.
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? Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis, Autoimmune Diseases, Autoimmune Diseases of the Nervous System
- What is being tested?
- Harvesting and Implantation of SVF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ageless Regenerative Institute LLC
Aventura, Florida, 33180
About this study
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
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?
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.
- Conditions
- Multiple Sclerosis, Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Nervous System Diseases
- Being tested
- Harvesting and Implantation of SVF
- Medical subject headings
- Multiple Sclerosis, Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvesting and Implantation of SVFProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Adipose SVF IV Infusion | Experimental | IV Infusion of Autologous Adipose Derived Stromal Vascular Fraction Intervention: Intravenous Infusion Receives: Procedure: Harvesting and Implantation of SVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement in disability score compared to baseline
Measured: 3 months
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.
Measured: up to 6 months
Clinical improvement in disability score compared to baseline
Measured: 6 months
Secondary outcomes (4)
MS disease activity measured by the number of Gd-enhancing brain MRI lesions
Measured: 3 months
Reduced number of relapses or freedom from progression of disease
Measured: 3 months
Reduced number of relapses or freedom from progression of disease
Measured: 6 months
MS disease activity measured by the number of Gd-enhancing brain MRI lesions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startApr 2016
- Primary completionDec 2018 (estimated)
- Study completionApr 2019 (estimated)
Why it stopped: company dissolved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ageless Regenerative Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon McQuillan, MD, Principal investigator, Ageless Regenerative Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453764
- Sponsor's protocol ID
- AD-US-MS-001
- Status last verified
- Aug 2017
- First submitted
- 3 Oct 2011
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01453764
- Acronym / sponsor ID
- AD-US-MS-001
- Conditions
- Multiple Sclerosis, Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: company dissolved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ageless Regenerative InstituteIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 18 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adipose SVF IV Infusion | Experimental | Procedure: Harvesting and Implantation of SVFIV Infusion of Autologous Adipose Derived Stromal Vascular Fraction Intervention: Intravenous Infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harvesting and Implantation of SVFThe 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. | Procedure or surgery | Adipose SVF IV Infusion |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon McQuillan, MD principal investigator
Ageless Regenerative Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harvesting and Implantation of SVF in people with Multiple Sclerosis and Autoimmune Diseases, run by Ageless Regenerative Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement in disability score compared to baseline (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.