Use of Stromal Vascular Fraction in Multiple Sclerosis

NCT03461419 | Suspended DMC FDA Device

• 1 other identifier: GARM-MS
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief 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). 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.

Conditions

Multiple Sclerosis; Autoimmune

Keywords

Multiple Sclerosis; Demyelinating Disease; Nervous System Degenerative Disease; Autoimmune Disease

Outcome Measures

Primary Outcomes (1)

• 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)

  6 month intervals for up to 5 years

Secondary Outcomes (3)

• Deficits of Neurologic Functioning prior to treatment

  6 month intervals for up to 5 years

• Quality of Life

  6 month

• Brain Lesions

  6 month interval minimum for up to 5 years

Study Arms (3)

Microcannula Harvest Adipose Stroma

EXPERIMENTAL

Acquisition of AD-tSVF via closed syringe microcannula

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)

Device: Centricyte 1000

Sterile Normal Saline IV

EXPERIMENTAL

Re-suspension of cSVF pellet in Sterile Normal Saline Intravenous Delivery

Procedure: Sterile Normal Saline IV Deployment of cSVF

Interventions

Microcannula Harvest Adipose Stroma PROCEDURE

Use of Disposable, Closed Syringe Microcannula Harvest Autologous Adipose Stroma and Stem/Stromal Cells

Microcannula Harvest Adipose Stroma

Centricyte 1000 DEVICE

Centricyte 1000 closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature

Centricyte 1000

Sterile Normal Saline IV Deployment of cSVF PROCEDURE

Sterile Normal Saline Suspension cSVF in 500 cc for Intravenous Delivery Including 150 micron in-line filtration

Sterile Normal Saline IV

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Healeon Medical Inc: lead
• Global Alliance for Regenerative Medicine: collaborator

Study Sites (2)

Robert W. Alexander, MD, FICS, LLC

Stevensville, Montana, 59870, United States

Location

Global Alliance of Regenerative Medicine (GARM) International

Roatán, Hn, Honduras, Honduras

Location

Related Publications (6)

• Tsang BK, Macdonell R. Multiple sclerosis- diagnosis, management and prognosis. Aust Fam Physician. 2011 Dec;40(12):948-55.

  PMID: 22146321 BACKGROUND

• Huntley 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.

  PMID: 16420779 BACKGROUND

• Hassan-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.

  PMID: 22082979 BACKGROUND

• Olsen 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.

  PMID: 19222053 BACKGROUND

• Luessi 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.

  PMID: 23039386 BACKGROUND

• Alexander 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.

  BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Demyelinating Diseases; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Immune System Diseases

Study Officials

• Glenn C Terry, MD

  GARM International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: March 12, 2018
• Study Start: August 1, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 15, 2028
• Last Updated: September 12, 2025

Record last verified: 2024-09

Locations

HO (1); US (1)