Multiple SclerosisGARM-MSNCT03461419
Use of Stromal Vascular Fraction in Multiple Sclerosis
A study testing Microcannula Harvest Adipose Stroma, Centricyte 1000 and Sterile Normal Saline IV Deployment of cSVF in people with Multiple Sclerosis and Autoimmune, run by Healeon Medical Inc at 2 sites in 2 countries.
Trial summary
Purpose of study is to determine safety and efficacy of use of autologous Adipose-Derived cellular Stromal Vascular Fraction (AD-cSVF) suspended in Normal Saline and delivered via intravascular system of quality of life and alteration of documented Advanced Muscular Sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Sclerosis, Autoimmune
- What is being tested?
- Microcannula Harvest Adipose Stroma, Centricyte 1000 and Sterile Normal Saline IV Deployment of cSVF
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2019to 15 Dec 2028
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented functional damage to central or peripheral nervous system unlikely to improve with present standard of care
- At least 6 months after onset of disease process
- If under current medical therapy (drug or surgical) for the condition, patient considered stable on that treatment and unlikely to have significant reversal of associated neurological functions damage as a result of ongoing treatments
- In estimation of providers and neurologists have the potential for improvement with AD-cSVF treatment, and be at minimal risk of potential harm from the procedure
- Over 18 year old, and capable of providing informed consent
- Medically stable and cleared by primary care physician, neurologist, or licensed practitioner that patient is felt to be reasonably expected to be expected to undergo procedures without known significant risk to health
Who cannot join
- Patient must be capable of an adequate neurologic examination and evaluation to document the pathology and ability to cooperate with examination
- Patient must be capable and willing to undergo follow up neurologic exams with investigators or their own neurologists
- Patient must be capable and competent to provide informed consent to participation
- In estimation of investigators, the patient may be at increased or significant risk of harm to the patient's general health or neurologic functions for collection of AD-cSVF collection
- Patients not medically stable, or who may be at significant risk to their health undergoing any and all procedures will not be eligible
- Women of childbearing age must not be pregnant at the time of treatment, and should refrain from becoming pregnant for 3 months post-treatment
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Robert W. Alexander, MD, FICS, LLC
Stevensville, Montana, 59870
Honduras1 site
Global Alliance of Regenerative Medicine (GARM) International
Roatán, Hn, Honduras
About this study
Official title: Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis
Purpose of study is to determine safety and efficacy of use of autologous Adipose-Derived cellular Stromal Vascular Fraction (AD-cSVF) suspended in Normal Saline and delivered via intravascular system of quality of life and alteration of documented Advanced Muscular Sclerosis (MS). It is believed that the heterogeneous cell population which includes multipotent stem/stromal cells plus non-multipotent cellular elements are capable of immune modulation/inflammatory modulation properties. Exam of disease progression and quality of life changes will be evaluated by sophisticated mathematical non-biased MRI analysis.
Read the detailed description
Advanced Multiple Sclerosis (MS), defined as a non-medication responsive MS, which is a demyelination disease which features damage to insulating covers of nerve cells in the brain and spinal cord. This damage or degenerative changes disrupts the ability of parts of the nervous system to communicate, resulting in range of signs and symptoms which include physical and mental changes.
Symptoms are variable and often include visual changes, sensory irregularities, and motor coordination. MS has several forms which result in new symptoms in either isolated attacks (relapsing forms) or gradual increasing symptoms (progressive forms). In most cases, severe side effects or non-responsive cases to traditional MS medications on the market, have not proven to be acceptable, totally safe (without severe side effects) or clinically efficacious.
While cause is not clear, mechanisms have been suggested association with loss of the immune system or failure to produce myelin-producing cells. Some suggest a genetic predisposition or environmental factor, but the exact causation in all cases have not been elucidated.
Medications have been developed, but remain modestly effective and possessing major side effects and poorly tolerated. Alternative treatments, including physical therapy and some stem/stromal therapies have become more common.
Three main characteristics of MS are: 1). Lesion formations in the central nervous system (called Plaques); 2). Inflammation; 3). Destruction of myelin sheaths of neurons. This demyelination is thought to stimulate the inflammatory processes due to action of a lymphocyte group known at T-cell which seems to recognize patient's own myelin as foreign and proceeds to attack it (known as "autoreactive lymphocytes").
Traditionally, exacerbation's are often treated with high dose intravenous steroids which may be of short term reduction of symptoms, not addressing the underlying causation. Current medications available for treatment are expensive and fraught with major side effects, making their use very difficult and producing limited measured value.
With the advent of convenient adipose harvesting and processing in closed systems, the ability to easily and safely acquire significant of stem/stromal cells, studies are underway to utilize autologous stem/stromal cells. This study is aimed at evaluation of the safety profile (adverse reactions \& severe adverse reaction) of the closed syringe, microcannula harvesting of subdermal fat deposits. This autologous cell group obtained with isolation and concentration of cells within the stromal vascular fraction (SVF) via enzymatic digestion, and deployed via intravascular routes. As these cells are very small, there is belief that they are able to pass into the cerebral fluids in defects of the blood brain barrier (BBB) or are small enough to pass into the fluids of the CNS (central nervous system).
Recent availability of a highly complex analytic program will be used to assess changes in the location, numbers, volumes, demyelination of brain lesions examined by MRI (with and without contrast). This is done as a comparative analysis at intervals of baseline to 6 month minimum, and annually as available for tracking of central nervous system (CNS) changes over time and correlated with clinical progressions.
- Conditions
- Multiple Sclerosis, Autoimmune
- Being tested
- Microcannula Harvest Adipose Stroma, Centricyte 1000, Sterile Normal Saline IV Deployment of cSVF
- Keywords
- Multiple Sclerosis, Demyelinating Disease, Nervous System Degenerative Disease, Autoimmune Disease
- Medical subject headings
- Multiple Sclerosis, Demyelinating Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcannula Harvest Adipose StromaProcedure or surgery
Use of Disposable, Closed Syringe Microcannula Harvest Autologous Adipose Stroma and Stem/Stromal Cells
Centricyte 1000Device
Centricyte 1000 closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature
Sterile Normal Saline IV Deployment of cSVFProcedure or surgery
Sterile Normal Saline Suspension cSVF in 500 cc for Intravenous Delivery Including 150 micron in-line filtration
| Study group | Role | What they receive |
|---|---|---|
| Microcannula Harvest Adipose Stroma | Experimental | Acquisition of AD-tSVF via closed syringe microcannula Receives: Procedure: Microcannula Harvest Adipose Stroma |
| Centricyte 1000 | Experimental | Autologous Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via enzymatic isolation/concentration closed system to create cellular stromal vascular fraction (cSVF) Receives: Device: Centricyte 1000 |
| Sterile Normal Saline IV | Experimental | Re-suspension of cSVF pellet in Sterile Normal Saline Intravenous Delivery Receives: Procedure: Sterile Normal Saline IV Deployment of cSVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events [Time Frame: Outcome measures evaluated at baseline and reviewed at 6 month intervals for average time frame of 5 years]
Activities of Daily Living (ADL)
Measured: 6 month intervals for up to 5 years
Secondary outcomes (3)
Deficits of Neurologic Functioning prior to treatment
Deficits of neurologic function identified by patient as impaired prior to treatment assessed. Examples: neurologic function may include speech, balance, motor/sensory actions, hearing, gait, strength, pain, paresthesias
Measured: 6 month intervals for up to 5 years
Quality of Life
Change from baseline in general quality of life (QoL) using Health status questionnaire (Doc-25)
Measured: 6 month
Brain Lesions
PIXYL software analysis change from baseline MRI with and without contrast; This is an objective standardized metric for analysis of demyelination, plaque formation, changes of number/volume and lessening or worsening of either data point. This is done at six month and one year minimum with option to do annually for up to 5 years
Measured: 6 month interval minimum for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Aug 2019
- Primary completion1 Jan 2027 (estimated)
- Study completion15 Dec 2028 (estimated)
Why it stopped: Withdrawn \[COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healeon Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Global Alliance for Regenerative Medicine
- Responsible party
- Principal investigator, Robert W. Alexander, MD, FICS, Healeon Medical Inc
- Investigators
- Glenn C Terry, MD, Principal investigator, GARM International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461419
- Sponsor's protocol ID
- GARM-MS
- Acronym
- GARM-MS
- Status last verified
- Sep 2024
- First submitted
- 23 Jan 2018
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Tsang BK, Macdonell R. Multiple sclerosis- diagnosis, management and prognosis. Aust Fam Physician. 2011 Dec;40(12):948-55.
PubMed 22146321Huntley A. A review of the evidence for efficacy of complementary and alternative medicines in MS. Int MS J. 2006 Jan;13(1):5-12, 4.
PubMed 16420779Hassan-Smith G, Douglas MR. Management and prognosis of multiple sclerosis. Br J Hosp Med (Lond). 2011 Nov;72(11):M174-6. doi: 10.12968/hmed.2011.72.sup11.m174.
PubMed 22082979Olsen SA. A review of complementary and alternative medicine (CAM) by people with multiple sclerosis. Occup Ther Int. 2009;16(1):57-70. doi: 10.1002/oti.266.
PubMed 19222053Luessi F, Siffrin V, Zipp F. Neurodegeneration in multiple sclerosis: novel treatment strategies. Expert Rev Neurother. 2012 Sep;12(9):1061-76; quiz 1077. doi: 10.1586/ern.12.59.
PubMed 23039386Alexander RW. Use of PIXYL software analysis of brain MRI (with & without contrast) as valuable metric in clinical trial tracking in study of multiple sclerosis (MS) and related neurodegenerative processes. Clin Trials Degener Dis 2017;2(1):1-10.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03461419
- Acronym / sponsor ID
- GARM-MS / GARM-MS
- Conditions
- Multiple Sclerosis, Autoimmune
- Keywords
- Multiple Sclerosis, Demyelinating Disease, Nervous System Degenerative Disease, Autoimmune Disease
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Withdrawn \[COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\]
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Healeon Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- Global Alliance for Regenerative Medicine
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 12 Mar 2018 (actual)
- 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.
Purpose of study is to determine safety and efficacy of use of autologous Adipose-Derived cellular Stromal Vascular Fraction (AD-cSVF) suspended in Normal Saline and delivered via intravascular system of quality of life and alteration of documented Advanced Muscular Sclerosis (MS). It is believed that the heterogeneous cell population which includes multipotent stem/stromal cells plus non-multipotent cellular elements are capable of immune modulation/inflammatory modulation properties. Exam of disease progression and quality of life changes will be evaluated by sophisticated mathematical non-biased MRI analysis.
Detailed description
Advanced Multiple Sclerosis (MS), defined as a non-medication responsive MS, which is a demyelination disease which features damage to insulating covers of nerve cells in the brain and spinal cord. This damage or degenerative changes disrupts the ability of parts of the nervous system to communicate, resulting in range of signs and symptoms which include physical and mental changes.
Symptoms are variable and often include visual changes, sensory irregularities, and motor coordination. MS has several forms which result in new symptoms in either isolated attacks (relapsing forms) or gradual increasing symptoms (progressive forms). In most cases, severe side effects or non-responsive cases to traditional MS medications on the market, have not proven to be acceptable, totally safe (without severe side effects) or clinically efficacious.
While cause is not clear, mechanisms have been suggested association with loss of the immune system or failure to produce myelin-producing cells. Some suggest a genetic predisposition or environmental factor, but the exact causation in all cases have not been elucidated.
Medications have been developed, but remain modestly effective and possessing major side effects and poorly tolerated. Alternative treatments, including physical therapy and some stem/stromal therapies have become more common.
Three main characteristics of MS are: 1). Lesion formations in the central nervous system (called Plaques); 2). Inflammation; 3). Destruction of myelin sheaths of neurons. This demyelination is thought to stimulate the inflammatory processes due to action of a lymphocyte group known at T-cell which seems to recognize patient's own myelin as foreign and proceeds to attack it (known as "autoreactive lymphocytes").
Traditionally, exacerbation's are often treated with high dose intravenous steroids which may be of short term reduction of symptoms, not addressing the underlying causation. Current medications available for treatment are expensive and fraught with major side effects, making their use very difficult and producing limited measured value.
With the advent of convenient adipose harvesting and processing in closed systems, the ability to easily and safely acquire significant of stem/stromal cells, studies are underway to utilize autologous stem/stromal cells. This study is aimed at evaluation of the safety profile (adverse reactions \& severe adverse reaction) of the closed syringe, microcannula harvesting of subdermal fat deposits. This autologous cell group obtained with isolation and concentration of cells within the stromal vascular fraction (SVF) via enzymatic digestion, and deployed via intravascular routes. As these cells are very small, there is belief that they are able to pass into the cerebral fluids in defects of the blood brain barrier (BBB) or are small enough to pass into the fluids of the CNS (central nervous system).
Recent availability of a highly complex analytic program will be used to assess changes in the location, numbers, volumes, demyelination of brain lesions examined by MRI (with and without contrast). This is done as a comparative analysis at intervals of baseline to 6 month minimum, and annually as available for tracking of central nervous system (CNS) changes over time and correlated with clinical progressions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microcannula Harvest Adipose Stroma | Experimental | Procedure: Microcannula Harvest Adipose StromaAcquisition of AD-tSVF via closed syringe microcannula |
| Centricyte 1000 | Experimental | Device: Centricyte 1000Autologous Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via enzymatic isolation/concentration closed system to create cellular stromal vascular fraction (cSVF) |
| Sterile Normal Saline IV | Experimental | Procedure: Sterile Normal Saline IV Deployment of cSVFRe-suspension of cSVF pellet in Sterile Normal Saline Intravenous Delivery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented functional damage to central or peripheral nervous system unlikely to improve with present standard of care
- At least 6 months after onset of disease process
- If under current medical therapy (drug or surgical) for the condition, patient considered stable on that treatment and unlikely to have significant reversal of associated neurological functions damage as a result of ongoing treatments
- In estimation of providers and neurologists have the potential for improvement with AD-cSVF treatment, and be at minimal risk of potential harm from the procedure
- Over 18 year old, and capable of providing informed consent
Key exclusion criteria (6 listed)
- Patient must be capable of an adequate neurologic examination and evaluation to document the pathology and ability to cooperate with examination
- Patient must be capable and willing to undergo follow up neurologic exams with investigators or their own neurologists
- Patient must be capable and competent to provide informed consent to participation
- In estimation of investigators, the patient may be at increased or significant risk of harm to the patient's general health or neurologic functions for collection of AD-cSVF collection
- Patients not medically stable, or who may be at significant risk to their health undergoing any and all procedures will not be eligible
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 |
|---|---|---|
| Microcannula Harvest Adipose StromaUse of Disposable, Closed Syringe Microcannula Harvest Autologous Adipose Stroma and Stem/Stromal Cells | Procedure or surgery | Microcannula Harvest Adipose Stroma |
| Centricyte 1000Centricyte 1000 closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature | Device | Centricyte 1000 |
| Sterile Normal Saline IV Deployment of cSVFSterile Normal Saline Suspension cSVF in 500 cc for Intravenous Delivery Including 150 micron in-line filtration | Procedure or surgery | Sterile Normal Saline IV |
Primary outcome
Number of participants with adverse events [Time Frame: Outcome measures evaluated at baseline and reviewed at 6 month intervals for average time frame of 5 years]
Time frame: 6 month intervals for up to 5 years
Activities of Daily Living (ADL)
3 secondary outcomes
Deficits of Neurologic Functioning prior to treatment
Time frame: 6 month intervals for up to 5 years
Quality of Life
Time frame: 6 month
Brain Lesions
Time frame: 6 month interval minimum for up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 22146321Tsang BK, Macdonell R. Multiple sclerosis- diagnosis, management and prognosis. Aust Fam Physician. 2011 Dec;40(12):948-55.
- Background: PubMed 16420779Huntley A. A review of the evidence for efficacy of complementary and alternative medicines in MS. Int MS J. 2006 Jan;13(1):5-12, 4.
- Background: PubMed 22082979Hassan-Smith G, Douglas MR. Management and prognosis of multiple sclerosis. Br J Hosp Med (Lond). 2011 Nov;72(11):M174-6. doi: 10.12968/hmed.2011.72.sup11.m174.
- Background: PubMed 19222053Olsen SA. A review of complementary and alternative medicine (CAM) by people with multiple sclerosis. Occup Ther Int. 2009;16(1):57-70. doi: 10.1002/oti.266.
- Background: PubMed 23039386Luessi F, Siffrin V, Zipp F. Neurodegeneration in multiple sclerosis: novel treatment strategies. Expert Rev Neurother. 2012 Sep;12(9):1061-76; quiz 1077. doi: 10.1586/ern.12.59.
- Results publicationAlexander RW. Use of PIXYL software analysis of brain MRI (with & without contrast) as valuable metric in clinical trial tracking in study of multiple sclerosis (MS) and related neurodegenerative processes. Clin Trials Degener Dis 2017;2(1):1-10.
- 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.
Glenn C Terry, MD principal investigator
GARM International
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microcannula Harvest Adipose Stroma, Centricyte 1000 and Sterile Normal Saline IV Deployment of cSVF in people with Multiple Sclerosis and Autoimmune, run by Healeon Medical Inc at 2 sites in 2 countries.
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 6 inclusion and 6 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: paused, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Honduras. 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?
Results are not available in the source record.
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?
Number of participants with adverse events [Time Frame: Outcome measures evaluated at baseline and reviewed at 6 month intervals for average time frame of 5 years] (time frame: 6 month intervals for up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03461419, which also lists 6 linked publications.
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 12 Sep 2025.