Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis,Autoimmune, Inflammatory, Neurologic Conditions

NCT02939859 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: RGV-GARM
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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 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.

Conditions

Multiple Sclerosis; Autoimmune

Keywords

Multiple Sclerosis; Demyelinating Diseases; Nervous System Diseases; Autoimmune Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Neurologic Functioning

  6 month intervals for up to 5 years

• Quality of Life Questionnairre

  1 year

• Fatigue

  6 month intervals for up to 5 years

• Cognitive Problems

  1 year intervals for up to 5 years

• Brain Lesions

  6 month intervals for up to 5 years

Study Arms (3)

Microcannula Harvest Adipose

EXPERIMENTAL

Acquisition AD-tSVF via closed syringe microcannula

Procedure: Microcannula Harvest Adipose

Centricyte 1000

EXPERIMENTAL

Autologous Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via enzymatic isolation/concentration via Centricyte 1000 Closed System to create AD-cSVF

Device: Centricyte 1000

Sterile Normal Saline

EXPERIMENTAL

Re-suspension of Autologous AD-cSVF pellet in Normal Saline deployment via IV

Procedure: Sterile Normal Saline IV deployment AD-cSVF

Interventions

Microcannula Harvest Adipose PROCEDURE

Use of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells

Microcannula Harvest Adipose

Centricyte 1000 DEVICE

Use of Centricyte 1000 closed system digestion adipose tissue stromal vascular fraction to create a AD-cSVF

Centricyte 1000

Sterile Normal Saline IV deployment AD-cSVF PROCEDURE

Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use

Sterile Normal Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Healeon Medical Inc: lead
• Global Alliance for Regenerative Medicine: collaborator

Study Sites (2)

Regenevita LLC

Stevensville, Montana, 59870, United States

Location

Global Alliance for Regenerative Medicine (GARM)

Roatán, Hn, Honduras

Location

Related Publications (20)

• 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.

  PMID: 22189514 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.

  PMID: 17444504 BACKGROUND

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

  PMID: 22146321 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.

  PMID: 16420779 BACKGROUND

• Weinshenker BG. Natural history of multiple sclerosis. Ann Neurol. 1994;36 Suppl:S6-11. doi: 10.1002/ana.410360704.

  PMID: 8017890 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.

  PMID: 14747002 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.

  PMID: 22041658 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 multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.

  PMID: 24871874 BACKGROUND

• 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.

  PMID: 23235682 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.

  PMID: 22782520 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.

  PMID: 22082979 BACKGROUND

• Freedman MS. Long-term follow-up of clinical trials of multiple sclerosis therapies. Neurology. 2011 Jan 4;76(1 Suppl 1):S26-34. doi: 10.1212/WNL.0b013e318205051d.

  PMID: 21205679 BACKGROUND

• Bates D. Treatment effects of immunomodulatory therapies at different stages of multiple sclerosis in short-term trials. Neurology. 2011 Jan 4;76(1 Suppl 1):S14-25. doi: 10.1212/WNL.0b013e3182050388.

  PMID: 21205678 BACKGROUND

• Martinelli Boneschi F, Vacchi L, Rovaris M, Capra R, Comi G. Mitoxantrone for multiple sclerosis. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD002127. doi: 10.1002/14651858.CD002127.pub3.

  PMID: 23728638 BACKGROUND

• Balak DM, Hengstman GJ, Cakmak A, Thio HB. Cutaneous adverse events associated with disease-modifying treatment in multiple sclerosis: a systematic review. Mult Scler. 2012 Dec;18(12):1705-17. doi: 10.1177/1352458512438239. Epub 2012 Feb 27.

  PMID: 22371220 BACKGROUND

• Comi G. Treatment of multiple sclerosis: role of natalizumab. Neurol Sci. 2009 Oct;30 Suppl 2:S155-8. doi: 10.1007/s10072-009-0147-2.

  PMID: 19882365 BACKGROUND

• Farinotti M, Vacchi L, Simi S, Di Pietrantonj C, Brait L, Filippini G. Dietary interventions for multiple sclerosis. Cochrane Database Syst Rev. 2012 Dec 12;12:CD004192. doi: 10.1002/14651858.CD004192.pub3.

  PMID: 23235605 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.

  PMID: 19222053 BACKGROUND

• Miller AE. Multiple sclerosis: where will we be in 2020? Mt Sinai J Med. 2011 Mar-Apr;78(2):268-79. doi: 10.1002/msj.20242.

  PMID: 21425270 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.

  PMID: 23039386 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Demyelinating Diseases; Nervous System Diseases; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Immune System Diseases

Study Officials

• Robert W Alexander, MD

  GARM International

  PRINCIPAL INVESTIGATOR

• Glenn C Terry, MD

  GARM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Science

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 20, 2016
• Study Start: December 15, 2018
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

HO (1); US (1)