Status:
SUSPENDED
Use of Stromal Vascular Fraction in Multiple Sclerosis
Lead Sponsor:
Healeon Medical Inc
Collaborating Sponsors:
Global Alliance for Regenerative Medicine
Conditions:
Multiple Sclerosis
Autoimmune
Eligibility:
All Genders
18-85 years
Phase:
NA
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...
Detailed Description
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. Th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03461419
Start Date
August 1 2019
End Date
December 15 2028
Last Update
September 12 2025
Active Locations (2)
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1
Robert W. Alexander, MD, FICS, LLC
Stevensville, Montana, United States, 59870
2
Global Alliance of Regenerative Medicine (GARM) International
Roatán, Hn, Honduras, Honduras