Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis,Autoim
Use of Cellular Stromal Vascular Fraction (cSVF) for Select Multiple Sclerosis, Autoimmune, Inflammatory, and Neurologic Conditions: Clinical Interventional Study of Adverse Events and Clinical Outcomes Using Autologous Stem-Stromal Cells.
What it found
The trial ended early for another reason (see below).
Reason given: Withdrawn \[COVID restrictions prevent patient enrollment or treatment.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
- Centricyte 1000
Placebo
- Sterile Normal Saline IV deployment AD-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 (5)
Neurologic Functioning
6 month intervals for up to 5 years
Walking and mobilityPhysical functionPainQuality of Life Questionnairre
1 year
Quality of life (reported by participants)Fatigue
6 month intervals for up to 5 years
FatigueCognitive Problems
1 year intervals for up to 5 years
Thinking and memoryBrain Lesions
6 month intervals 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 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
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 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.
Papers
Background
Nakahara J, Maeda M, Aiso S, Suzuki N. Current concepts in multiple sclerosis: autoimmunity versus oligodendrogliopathy. Clin Rev Allergy Immunol. 2012 Feb;42(1):26-34. doi: 10.1007/s12016-011-8287-6.Background
Ascherio A, Munger KL. Environmental risk factors for multiple sclerosis. Part I: the role of infection. Ann Neurol. 2007 Apr;61(4):288-99. doi: 10.1002/ana.21117.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
Weinshenker BG. Natural history of multiple sclerosis. Ann Neurol. 1994;36 Suppl:S6-11. doi: 10.1002/ana.410360704.Background
Dyment DA, Ebers GC, Sadovnick AD. Genetics of multiple sclerosis. Lancet Neurol. 2004 Feb;3(2):104-10. doi: 10.1016/s1474-4422(03)00663-x.Background
Hassan-Smith G, Douglas MR. Epidemiology and diagnosis of multiple sclerosis. Br J Hosp Med (Lond). 2011 Oct;72(10):M146-51. doi: 10.12968/hmed.2011.72.sup10.m146.Background
Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multBackground
He D, Xu Z, Dong S, Zhang H, Zhou H, Wang L, Zhang S. Teriflunomide for multiple sclerosis. Cochrane Database Syst Rev. 2012 Dec 12;12:CD009882. doi: 10.1002/14651858.CD009882.pub2.Background
Manouchehrinia A, Constantinescu CS. Cost-effectiveness of disease-modifying therapies in multiple sclerosis. Curr Neurol Neurosci Rep. 2012 Oct;12(5):592-600. doi: 10.1007/s11910-012-0291-6.
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History
Started
Dec 2018
Main results due
Oct 2022
Finished
Oct 2023