Use of Stromal Vascular Fraction in Advanced Multiple Sclerosis (GARM-MS)
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|ClinicalTrials.gov Identifier: NCT03461419|
Recruitment Status : Enrolling by invitation
First Posted : March 12, 2018
Last Update Posted : November 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Autoimmune||Procedure: Microcannula Harvest Adipose Stroma Device: Centricyte 1000 Procedure: Sterile Normal Saline IV Deployment of cSVF||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Cellular Stromal Vascular Fraction in Advanced Multiple Sclerosis|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
Experimental: Microcannula Harvest Adipose Stroma
Acquisition of AD-tSVF via closed syringe microcannula
Procedure: Microcannula Harvest Adipose Stroma
Use of Disposable, Closed Syringe Microcannula Harvest Autologous Adipose Stroma and Stem/Stromal Cells
Experimental: Centricyte 1000
Autologous Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via enzymatic isolation/concentration closed system to create cellular stromal vascular fraction (cSVF)
Device: Centricyte 1000
Centricyte 1000 closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature
Experimental: Sterile Normal Saline IV
Re-suspension of cSVF pellet in Sterile Normal Saline Intravenous Delivery
Procedure: Sterile Normal Saline IV Deployment of cSVF
Sterile Normal Saline Suspension cSVF in 500 cc for Intravenous Delivery Including 150 micron in-line filtration
- 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)
- Deficits of Neurologic Functioning prior to treatment [ Time Frame: 6 month intervals for up to 5 years ]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
- Quality of Life [ Time Frame: 6 month ]Change from baseline in general quality of life (QoL) using Health status questionnaire (Doc-25)
- Brain Lesions [ Time Frame: 6 month interval minimum for up to 5 years ]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
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): NCT03461419
|United States, Montana|
|Robert W. Alexander, MD, FICS, LLC|
|Stevensville, Montana, United States, 59870|
|Global Alliance of Regenerative Medicine (GARM) International|
|Roatan, Hn, Honduras, Honduras|
|Principal Investigator:||Glenn C Terry, MD||GARM International|