Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis,Autoimmune, Inflammatory, Neurologic Conditions (cSVF)
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|ClinicalTrials.gov Identifier: NCT02939859|
Recruitment Status : Enrolling by invitation
First Posted : October 20, 2016
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Autoimmune||Procedure: Microcannula Harvest Adipose Device: Centricyte 1000 Procedure: Sterile Normal Saline IV deployment AD-cSVF||Not Applicable|
Multiple Sclerosis (MS) 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).
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Cellular Stromal Vascular Fraction (cSVF) for Select Multiple Sclerosis, Autoimmune, Inflammatory, and Neurologic Conditions: Clinical Interventional Study of Adverse Events and Clinical Outcomes Using Autologous Stem-Stromal Cells.|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2023|
Experimental: Microcannula Harvest Adipose
Acquisition AD-tSVF via closed syringe microcannula
Procedure: Microcannula Harvest Adipose
Use of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells
Experimental: Centricyte 1000
Autologous Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via enzymatic isolation/concentration via Centricyte 1000 Closed System to create AD-cSVF
Device: Centricyte 1000
Use of Centricyte 1000 closed system digestion adipose tissue stromal vascular fraction to create a AD-cSVF
Experimental: Sterile Normal Saline
Re-suspension of Autologous AD-cSVF pellet in Normal Saline deployment via IV
Procedure: Sterile Normal Saline IV deployment AD-cSVF
Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use
- 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)
- Neurologic Functioning [ 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 intervals for up to 5 years ]Change from baseline in overall General Quality of Life (GQL) Health status questionnaire (SF-36)
- Fatigue [ Time Frame: 6 month intervals for up to 5 years ]Change from baseline measured by modified fatigue impact scale (MFIS)
- Pain [ Time Frame: 6 month intervals for up to 5 years ]Change from baseline in pain and sensory symptoms measurement of symptoms (MOS) pain effects scale (PES)
- Cognitive Problems [ Time Frame: 1 year intervals for up to 5 years ]Cognitive Problems measured by Perceived Deficits Questionnaire (PDQ)
- Brain Lesions [ Time Frame: 6 month intervals for up to 5 years ]PIXYL Software Analysis from Baseline and at 6 month MRI with/without contrast Brain
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): NCT02939859
|United States, Montana|
|Stevensville, Montana, United States, 59870|
|Global Alliance for Regenerative Medicine (GARM)|
|Roatan, Hn, Honduras|
|Principal Investigator:||Robert W Alexander, MD||GARM International|
|Principal Investigator:||Glenn C Terry, MD||GARM|