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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03461419




Registration number
NCT03461419
Ethics application status
Date submitted
23/01/2018
Date registered
12/03/2018
Date last updated
1/10/2024

Titles & IDs
Public title
Use of Stromal Vascular Fraction in Multiple Sclerosis
Scientific title
Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis
Secondary ID [1] 0 0
GARM-MS
Universal Trial Number (UTN)
Trial acronym
GARM-MS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Autoimmune 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Microcannula Harvest Adipose Stroma
Treatment: Devices - Centricyte 1000
Treatment: Surgery - Sterile Normal Saline IV Deployment of cSVF

Experimental: Microcannula Harvest Adipose Stroma - Acquisition of AD-tSVF via closed syringe microcannula

Experimental: Centricyte 1000 - Autologous Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via enzymatic isolation/concentration closed system to create cellular stromal vascular fraction (cSVF)

Experimental: Sterile Normal Saline IV - Re-suspension of cSVF pellet in Sterile Normal Saline Intravenous Delivery


Treatment: Surgery: Microcannula Harvest Adipose Stroma
Use of Disposable, Closed Syringe Microcannula Harvest Autologous Adipose Stroma and Stem/Stromal Cells

Treatment: Devices: Centricyte 1000
Centricyte 1000 closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature

Treatment: Surgery: Sterile Normal Saline IV Deployment of cSVF
Sterile Normal Saline Suspension cSVF in 500 cc for Intravenous Delivery Including 150 micron in-line filtration
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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]
Timepoint [1] 0 0
6 month intervals for up to 5 years
Secondary outcome [1] 0 0
Deficits of Neurologic Functioning prior to treatment
Timepoint [1] 0 0
6 month intervals for up to 5 years
Secondary outcome [2] 0 0
Quality of Life
Timepoint [2] 0 0
6 month
Secondary outcome [3] 0 0
Brain Lesions
Timepoint [3] 0 0
6 month interval minimum for up to 5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Montana
Country [2] 0 0
Honduras
State/province [2] 0 0
Hn

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Healeon Medical Inc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Global Alliance for Regenerative Medicine
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/study/NCT03461419
Trial related presentations / publications
Tsang BK, Macdonell R. Multiple sclerosis- diagnosis, management and prognosis. Aust Fam Physician. 2011 Dec;40(12):948-55.
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.
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.
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.
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.
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.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Glenn C Terry, MD
Address 0 0
GARM International
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03461419