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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03461419
Other study ID # GARM-MS
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date December 15, 2024

Study information

Verified date August 2022
Source Healeon Medical Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Microcannula Harvest Adipose Stroma
Use of Disposable, Closed Syringe Microcannula Harvest Autologous Adipose Stroma and Stem/Stromal Cells
Device:
Centricyte 1000
Centricyte 1000 closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature
Procedure:
Sterile Normal Saline IV Deployment of cSVF
Sterile Normal Saline Suspension cSVF in 500 cc for Intravenous Delivery Including 150 micron in-line filtration

Locations

Country Name City State
Honduras Global Alliance of Regenerative Medicine (GARM) International Roatan Hn
United States Robert W. Alexander, MD, FICS, LLC Stevensville Montana

Sponsors (2)

Lead Sponsor Collaborator
Healeon Medical Inc Global Alliance for Regenerative Medicine

Countries where clinical trial is conducted

United States,  Honduras, 

References & Publications (6)

Alexander RW. Use of PIXYL software analysis of brain MRI (with & without contrast) as valuable metric in clinical trial tracking in study of multiple sclerosis (MS) and related neurodegenerative processes. Clin Trials Degener Dis 2017;2(1):1-10.

Hassan-Smith G, Douglas MR. Management and prognosis of multiple sclerosis. Br J Hosp Med (Lond). 2011 Nov;72(11):M174-6. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Tsang BK, Macdonell R. Multiple sclerosis- diagnosis, management and prognosis. Aust Fam Physician. 2011 Dec;40(12):948-55. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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] Activities of Daily Living (ADL) 6 month intervals for up to 5 years
Secondary Deficits of Neurologic Functioning prior to treatment Deficits of neurologic function identified by patient as impaired prior to treatment assessed. Examples: neurologic function may include speech, balance, motor/sensory actions, hearing, gait, strength, pain, paresthesias 6 month intervals for up to 5 years
Secondary Quality of Life Change from baseline in general quality of life (QoL) using Health status questionnaire (Doc-25) 6 month
Secondary Brain Lesions PIXYL software analysis change from baseline MRI with and without contrast; This is an objective standardized metric for analysis of demyelination, plaque formation, changes of number/volume and lessening or worsening of either data point. This is done at six month and one year minimum with option to do annually for up to 5 years 6 month interval minimum for up to 5 years
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