Use of Stromal Vascular Fraction in Multiple Sclerosis

Paused · Not applicable

Conditions studied: Multiple Sclerosis, Autoimmune

In brief

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.

Key facts

Study ID: NCT03461419
Run by: Healeon Medical Inc
People needed: 100
Starts: 2019-08-01
Expected to finish: 2028-12-15
Last updated by the study team: 2025-09-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Robert W. Alexander, MD, FICS, LLC — Stevensville, Montana, United States
Global Alliance of Regenerative Medicine (GARM) International — Roatán, Hn, Honduras

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.