Use of Stromal Vascular Fraction in Multiple Sclerosis
Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis
What it found
No result yet.
Reason given: Withdrawn \[COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\]
What was tested
Treatment tested
- Microcannula Harvest Adipose Stroma
- Centricyte 1000
Placebo
- Sterile Normal Saline IV Deployment of cSVF
What it measured
Main measures
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]
6 month intervals for up to 5 years
Safety
Other measures (3)
Deficits of Neurologic Functioning prior to treatment
6 month intervals for up to 5 years
Walking and mobilityPhysical functionPainQuality of Life
6 month
Quality of life (reported by participants)Brain Lesions
6 month interval minimum for up to 5 years
MRI lesions
Who could take part
MS (type not specified) · 18 to 85
Show the full criteria
Inclusion criteria
* 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 criteria
* 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
Tsang BK, Macdonell R. Multiple sclerosis- diagnosis, management and prognosis. Aust Fam Physician. 2011 Dec;40(12):948-55.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.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.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.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.
Loading reviews and guidelines…
History
Started
Aug 2019
Main results due
Jan 2027
Finished
Dec 2028