Autologous Stem/Stromal Cells in Neurological Disorders and Disease
NDD
Use Of Autologous Stem Cell Use In Neurological Non-neoplastic Disorders And Disease
1 other identifier
interventional
300
1 country
2
Brief Summary
The study deals with evaluation of safety and efficacy of use of stem/stromal cell isolates from autologous microvasculature in neurological, non-neoplastic disease. Autologous cells are acquired via microcannula aspiration of subdermal fat deposits, isolated through a digestive process, and concentrated via standard centrifugation. The cellular stromal vascular fraction (cSVF) created is neutralized and rinsed to eliminate residual enzymatic molecules. These cells are suspending in sterile Normal Saline Solution (500cc) and re-administered via an intravenous parenteral route, passed through a standard sterile 150 u (micron) filter in line. Multiple tracking and questionnaire followup is intended over a 5 year period, with objective and subjective criteria being met. Compilation and analysis of data to be completed after that period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2017
CompletedFirst Posted
Study publicly available on registry
September 29, 2017
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedOctober 18, 2018
October 1, 2018
3 years
September 26, 2017
October 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participant with adverse events (AE) or severe adverse events (SAE)
Activities of Daily Living (ADL)
6 month intervals for up to 5 years
Secondary Outcomes (3)
Neurological Function
6 month Intervals for up to 5 years
Neurological Tested Functions
6 month interval for up to 5 years
Magnetic Resonance Imaging (MRI)
6 month intervals for up to 5 years
Study Arms (3)
Microcannula Harvest Adipose
EXPERIMENTALAcquisition AD-tSVF Via Closed Syringe Microcannula
Centricyte 1000
EXPERIMENTALAutologous Adipose-Derived Tissue Stromal Vascular Fraction (tSVF) via enzymatic digestive isolation \& concentration in Centricyte 1000 closed system to create AD-cSVF
Sterile Normal Saline Infusion
EXPERIMENTALSterile Normal Saline to Re-Suspend Autologous cSVF pellet for delivery via intravascular (IV) route
Interventions
Use Closed Syringe Microcannula Harvest Adipose, Autologous Subdermal Deposits
Sterile Normal Saline Re-Suspension of cSVF and Delivery of AD-cSVF via IV route
Eligibility Criteria
You may qualify if:
- Documented Functional Neurological Damage To Central or Peripheral Nervous System Unlikely To Improve With Present Standard of Care Approaches
- At least 6 months after onset or diagnosis of disease process
- Current Medical therapy for the condition is either failing or not tolerated by patient
- Patient must be capable of interval neurologic exams with investigators or their own neurologic specialists
- Patient must be capable and determined competent to provide detailed informed consent for study participation
- In estimation of investigators, that there are minimal or no significant risk of harm to general health or conditions for collection of autologous stem cell collection and use
You may not qualify if:
- Inability of patient to have diagnostic examinations or studies (MRI) to evaluate and document the disease state or unwilling/unable to cooperate with such documentation
- Patients not medically stable, or whom may have ongoing conditions which increases may place the patient at significant risk of major complications, to be determined by investigator or patient's medical provider or neurologic specialists
- History of active cancer or ongoing anticancer therapy within six months of such care
- Women of childbearing age must not be pregnant at the time of treatment, and should refrain from becoming pregnant of at minimum of 3 month after study treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneris Medicallead
- Global Alliance for Regenerative Medicinecollaborator
- Robert W. Alexander, MD, FICScollaborator
- Regeneris Medical Inccollaborator
Study Sites (2)
Regeneris Medical Inc
North Attleboro, Massachusetts, 02760, United States
Regeneris Medical
North Attleboro, Massachusetts, 02760, United States
Related Publications (9)
Litvan I, Agid Y, Goetz C, Jankovic J, Wenning GK, Brandel JP, Lai EC, Verny M, Ray-Chaudhuri K, McKee A, Jellinger K, Pearce RK, Bartko JJ. Accuracy of the clinical diagnosis of corticobasal degeneration: a clinicopathologic study. Neurology. 1997 Jan;48(1):119-25. doi: 10.1212/wnl.48.1.119.
PMID: 9008506BACKGROUNDRizzo G, Martinelli P, Manners D, Scaglione C, Tonon C, Cortelli P, Malucelli E, Capellari S, Testa C, Parchi P, Montagna P, Barbiroli B, Lodi R. Diffusion-weighted brain imaging study of patients with clinical diagnosis of corticobasal degeneration, progressive supranuclear palsy and Parkinson's disease. Brain. 2008 Oct;131(Pt 10):2690-700. doi: 10.1093/brain/awn195. Epub 2008 Sep 26.
PMID: 18819991BACKGROUNDAlladi S, Xuereb J, Bak T, Nestor P, Knibb J, Patterson K, Hodges JR. Focal cortical presentations of Alzheimer's disease. Brain. 2007 Oct;130(Pt 10):2636-45. doi: 10.1093/brain/awm213.
PMID: 17898010BACKGROUNDSha SJ, Ghosh PM, Lee SE, Corbetta-Rastelli C, Jagust WJ, Kornak J, Rankin KP, Grinberg LT, Vinters HV, Mendez MF, Dickson DW, Seeley WW, Gorno-Tempini M, Kramer J, Miller BL, Boxer AL, Rabinovici GD. Predicting amyloid status in corticobasal syndrome using modified clinical criteria, magnetic resonance imaging and fluorodeoxyglucose positron emission tomography. Alzheimers Res Ther. 2015 Mar 2;7(1):8. doi: 10.1186/s13195-014-0093-y. eCollection 2015.
PMID: 25733984BACKGROUNDJankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
PMID: 18344392BACKGROUNDGibb WR, Lees AJ. The relevance of the Lewy body to the pathogenesis of idiopathic Parkinson's disease. J Neurol Neurosurg Psychiatry. 1988 Jun;51(6):745-52. doi: 10.1136/jnnp.51.6.745.
PMID: 2841426BACKGROUNDPedrosa DJ, Timmermann L. Review: management of Parkinson's disease. Neuropsychiatr Dis Treat. 2013;9:321-40. doi: 10.2147/NDT.S32302. Epub 2013 Mar 3.
PMID: 23487540BACKGROUNDMayo L, Quintana FJ, Weiner HL. The innate immune system in demyelinating disease. Immunol Rev. 2012 Jul;248(1):170-87. doi: 10.1111/j.1600-065X.2012.01135.x.
PMID: 22725961BACKGROUNDRansohoff RM, Howe CL, Rodriguez M. Growth factor treatment of demyelinating disease: at last, a leap into the light. Trends Immunol. 2002 Nov;23(11):512-6. doi: 10.1016/s1471-4906(02)02321-9.
PMID: 12401395BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan Welter, MD, PhD
Regeneris Medical Inc
- PRINCIPAL INVESTIGATOR
Glenn C Terry
Global Alliance for Regenerative Medicine (GARM)
- PRINCIPAL INVESTIGATOR
Robert W Alexander, MD
Healeon Medical
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Science
Study Record Dates
First Submitted
September 26, 2017
First Posted
September 29, 2017
Study Start
January 1, 2020
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
October 18, 2018
Record last verified: 2018-10