Multiple SclerosisPhase 1cSVFNCT02939859
Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis,Autoimmune, Inflammatory, Neurologic Conditions
A Phase 1 study testing Microcannula Harvest Adipose, Centricyte 1000 and Sterile Normal Saline IV deployment AD-cSVF in people with Multiple Sclerosis and Autoimmune, run by Healeon Medical Inc at 2 sites in 2 countries.
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 Muscular Sclerosis (MS) and related neurodegenerative patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Sclerosis, Autoimmune
- What is being tested?
- Microcannula Harvest Adipose, Centricyte 1000 and Sterile Normal Saline IV deployment AD-cSVF
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Dec 2018to Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
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.
Read the detailed description
Multiple Sclerosis (MS) is a demyelination disease which features damage to insulating covers of nerve cells in the brain and spinal cord. This damage or degenerative changes disrupts the ability of parts of the nervous system to communicate, resulting in range of signs and symptoms which include physical and mental changes.
Symptoms are variable and often include visual changes, sensory irregularities, and motor coordination. MS has several forms which result in new symptoms in either isolated attacks (relapsing forms) or gradual increasing symptoms (progressive forms).
While cause is not clear, mechanisms have been suggested association with loss of the immune system or failure to produce myelin-producing cells. Some suggest a genetic predisposition or environmental factor, but the exact causation in all cases have not been elucidated.
Medications have been developed, but remain modestly effective and possessing major side effects and poorly tolerated. Alternative treatments, including physical therapy and some stem/stromal therapies have become more common.
Three main characteristics of MS are: 1). Lesion formations in the central nervous system (called Plaques); 2). Inflammation; 3). Destruction of myelin sheaths of neurons. This demyelination is thought to stimulate the inflammatory processes due to action of a lymphocyte group known at T-cell which seems to recognize patient's own myelin as foreign and proceeds to attack it (known as "autoreactive lymphocytes").
Traditionally, exacerbation's are often treated with high dose intravenous steroids which may be of short term reduction of symptoms, not addressing the underlying causation. Current medications available for treatment are expensive and fraught with major side effects, making their use very difficult and producing limited measured value.
With the advent of convenient adipose harvesting and processing in closed systems, the ability to easily and safely acquire significant of stem/stromal cells, studies are underway to utilize autologous stem/stromal cells. This study is aimed at evaluation of the safety profile (adverse reactions \& severe adverse reaction) of the closed syringe, microcannula harvesting of subdermal fat deposits. This autologous cell group obtained with isolation and concentration of cells within the stromal vascular fraction (SVF) via enzymatic digestion, and deployed via intravascular routes. As these cells are very small, there is belief that they are able to pass into the cerebral fluids in defects of the blood brain barrier (BBB) or are small enough to pass into the fluids of the CNS (central nervous system).
- Conditions
- Multiple Sclerosis, Autoimmune
- Being tested
- Microcannula Harvest Adipose, Centricyte 1000, Sterile Normal Saline IV deployment AD-cSVF
- Keywords
- Multiple Sclerosis, Demyelinating Diseases, Nervous System Diseases, Autoimmune Disorders
- Medical subject headings
- Multiple Sclerosis, Demyelinating Diseases, Nervous System Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcannula Harvest AdiposeProcedure or surgery
Use of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells
Centricyte 1000Device
Use of Centricyte 1000 closed system digestion adipose tissue stromal vascular fraction to create a AD-cSVF
Sterile Normal Saline IV deployment AD-cSVFProcedure or surgery
Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use
| Study group | Role | What they receive |
|---|---|---|
| Microcannula Harvest Adipose | Experimental | Acquisition AD-tSVF via closed syringe microcannula Receives: 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 Receives: Device: Centricyte 1000 |
| Sterile Normal Saline | Experimental | Re-suspension of Autologous AD-cSVF pellet in Normal Saline deployment via IV Receives: Procedure: Sterile Normal Saline IV deployment AD-cSVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 month intervals for up to 5 years
Secondary outcomes (5)
Neurologic Functioning
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
Measured: 6 month intervals for up to 5 years
Quality of Life Questionnairre
Change from baseline in overall General Quality of Life (GQL) Health status questionnaire (SF-36)
Measured: 1 year
Fatigue
Change from baseline measured by modified fatigue impact scale (MFIS)
Measured: 6 month intervals for up to 5 years
Cognitive Problems
Cognitive Problems measured by Perceived Deficits Questionnaire (PDQ)
Measured: 1 year intervals for up to 5 years
Brain Lesions
PIXYL Software Analysis from Baseline and at 6 month MRI with/without contrast Brain
Measured: 6 month intervals for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start15 Dec 2018
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: Withdrawn \[COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healeon Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Global Alliance for Regenerative Medicine
- Responsible party
- Principal investigator, Robert W. Alexander, MD, FICS, Healeon Medical Inc
- Investigators
- Robert W Alexander, MD, Principal investigator, GARM InternationalGlenn C Terry, MD, Principal investigator, GARM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939859
- Sponsor's protocol ID
- RGV-GARM
- Acronym
- cSVF
- Status last verified
- Feb 2021
- First submitted
- 3 Oct 2016
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Annual Summary of Cases to All Collaborators
Publications
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.
PubMed 22189514Ascherio 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.
PubMed 17444504Tsang BK, Macdonell R. Multiple sclerosis- diagnosis, management and prognosis. Aust Fam Physician. 2011 Dec;40(12):948-55.
PubMed 22146321Huntley 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.
PubMed 16420779Weinshenker BG. Natural history of multiple sclerosis. Ann Neurol. 1994;36 Suppl:S6-11. doi: 10.1002/ana.410360704.
PubMed 8017890Dyment 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.
PubMed 14747002Hassan-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.
PubMed 22041658Lublin 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.
PubMed 24871874He 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.
PubMed 23235682Manouchehrinia 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.
PubMed 22782520Hassan-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.
PubMed 22082979Freedman 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.
PubMed 21205679Bates 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.
PubMed 21205678Martinelli 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.
PubMed 23728638Balak 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.
PubMed 22371220
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02939859
- Acronym / sponsor ID
- cSVF / RGV-GARM
- Conditions
- Multiple Sclerosis, Autoimmune
- Keywords
- Multiple Sclerosis, Demyelinating Diseases, Nervous System Diseases, Autoimmune Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn \[COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\]
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Healeon Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- Global Alliance for Regenerative Medicine
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multiple Sclerosis (MS) is a demyelination disease which features damage to insulating covers of nerve cells in the brain and spinal cord. This damage or degenerative changes disrupts the ability of parts of the nervous system to communicate, resulting in range of signs and symptoms which include physical and mental changes.
Symptoms are variable and often include visual changes, sensory irregularities, and motor coordination. MS has several forms which result in new symptoms in either isolated attacks (relapsing forms) or gradual increasing symptoms (progressive forms).
While cause is not clear, mechanisms have been suggested association with loss of the immune system or failure to produce myelin-producing cells. Some suggest a genetic predisposition or environmental factor, but the exact causation in all cases have not been elucidated.
Medications have been developed, but remain modestly effective and possessing major side effects and poorly tolerated. Alternative treatments, including physical therapy and some stem/stromal therapies have become more common.
Three main characteristics of MS are: 1). Lesion formations in the central nervous system (called Plaques); 2). Inflammation; 3). Destruction of myelin sheaths of neurons. This demyelination is thought to stimulate the inflammatory processes due to action of a lymphocyte group known at T-cell which seems to recognize patient's own myelin as foreign and proceeds to attack it (known as "autoreactive lymphocytes").
Traditionally, exacerbation's are often treated with high dose intravenous steroids which may be of short term reduction of symptoms, not addressing the underlying causation. Current medications available for treatment are expensive and fraught with major side effects, making their use very difficult and producing limited measured value.
With the advent of convenient adipose harvesting and processing in closed systems, the ability to easily and safely acquire significant of stem/stromal cells, studies are underway to utilize autologous stem/stromal cells. This study is aimed at evaluation of the safety profile (adverse reactions \& severe adverse reaction) of the closed syringe, microcannula harvesting of subdermal fat deposits. This autologous cell group obtained with isolation and concentration of cells within the stromal vascular fraction (SVF) via enzymatic digestion, and deployed via intravascular routes. As these cells are very small, there is belief that they are able to pass into the cerebral fluids in defects of the blood brain barrier (BBB) or are small enough to pass into the fluids of the CNS (central nervous system).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microcannula Harvest Adipose | Experimental | Procedure: Microcannula Harvest AdiposeAcquisition AD-tSVF via closed syringe microcannula |
| Centricyte 1000 | Experimental | Device: Centricyte 1000Autologous Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via enzymatic isolation/concentration via Centricyte 1000 Closed System to create AD-cSVF |
| Sterile Normal Saline | Experimental | Procedure: Sterile Normal Saline IV deployment AD-cSVFRe-suspension of Autologous AD-cSVF pellet in Normal Saline deployment via IV |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microcannula Harvest AdiposeUse of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells | Procedure or surgery | Microcannula Harvest Adipose |
| Centricyte 1000Use of Centricyte 1000 closed system digestion adipose tissue stromal vascular fraction to create a AD-cSVF | Device | Centricyte 1000 |
| Sterile Normal Saline IV deployment AD-cSVFSterile Normal Saline Suspension AD-cSVF in 500 cc IV use | Procedure or surgery | Sterile Normal Saline |
Primary outcome
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]
Time frame: 6 month intervals for up to 5 years
Activities of Daily Living (ADL)
5 secondary outcomes
Neurologic Functioning
Time frame: 6 month intervals for up to 5 years
Quality of Life Questionnairre
Time frame: 1 year
Fatigue
Time frame: 6 month intervals for up to 5 years
Cognitive Problems
Time frame: 1 year intervals for up to 5 years
Brain Lesions
Time frame: 6 month intervals for up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Background: PubMed 22189514Nakahara 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: PubMed 17444504Ascherio 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: PubMed 22146321Tsang BK, Macdonell R. Multiple sclerosis- diagnosis, management and prognosis. Aust Fam Physician. 2011 Dec;40(12):948-55.
- Background: PubMed 16420779Huntley 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: PubMed 8017890Weinshenker BG. Natural history of multiple sclerosis. Ann Neurol. 1994;36 Suppl:S6-11. doi: 10.1002/ana.410360704.
- Background: PubMed 14747002Dyment 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: PubMed 22041658Hassan-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: PubMed 24871874Lublin 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.
- Background: PubMed 23235682He 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: PubMed 22782520Manouchehrinia 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.
- Background: PubMed 22082979Hassan-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: PubMed 21205679Freedman 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.
- Individual participant dataSharing planned: Undecided. Annual Summary of Cases to All Collaborators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Alexander, MD principal investigator
GARM International
Glenn C Terry, MD principal investigator
GARM
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microcannula Harvest Adipose, Centricyte 1000 and Sterile Normal Saline IV deployment AD-cSVF in people with Multiple Sclerosis and Autoimmune, run by Healeon Medical Inc at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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] (time frame: 6 month intervals for up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02939859, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.