Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis,Autoimmune, Inflammatory, Neurologic Conditions

Withdrawn before enrolling · Phase 1

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 Muscular Sclerosis (MS) and related neurodegenerative patients. It is believed that the heterogeneous cell population which includes multipotent stem/stromal cells are capable of immune modulation/inflammatory modulation properties. Exam of disease progression and quality of life changes will be evaluated.

Key facts

Study ID

NCT02939859

Run by

Healeon Medical Inc

People needed

0

Starts

2018-12-15

Expected to finish

2023-10-01

Last updated by the study team

2021-02-16

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 much 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

• Regenevita LLC — Stevensville, Montana, United States
• Global Alliance for Regenerative Medicine (GARM) — Roatán, Hn, Honduras

Full record on ClinicalTrials.gov

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