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Autologous Stem/Stromal Cells in Neurological Disorders and Disease (NDD)

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ClinicalTrials.gov Identifier: NCT03297177
Recruitment Status : Not yet recruiting
First Posted : September 29, 2017
Last Update Posted : October 18, 2018
Sponsor:
Collaborators:
Global Alliance for Regenerative Medicine
Robert W. Alexander, MD, FICS
Regeneris Medical Inc
Information provided by (Responsible Party):
Ryan Welter, MD, PhD, Healeon Medical Inc

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.


Condition or disease Intervention/treatment Phase
Dementia Parkinson Altered Behavior in Alzheimer Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Sensorimotor Neuropathy Corticobasal Degeneration Procedure: Microcannula Harvest Adipose Device: Centricyte 1000 Procedure: Sterile Normal Saline Infusion Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use Of Autologous Stem Cell Use In Neurological Non-neoplastic Disorders And Disease
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023


Arm Intervention/treatment
Experimental: Microcannula Harvest Adipose
Acquisition AD-tSVF Via Closed Syringe Microcannula
Procedure: Microcannula Harvest Adipose
Use Closed Syringe Microcannula Harvest Adipose, Autologous Subdermal Deposits

Experimental: Centricyte 1000
Autologous Adipose-Derived Tissue Stromal Vascular Fraction (tSVF) via enzymatic digestive isolation & concentration in Centricyte 1000 closed system to create AD-cSVF
Device: Centricyte 1000
Closed System, Digestive Isolation & Concentration of AD-cSVF

Experimental: Sterile Normal Saline Infusion
Sterile Normal Saline to Re-Suspend Autologous cSVF pellet for delivery via intravascular (IV) route
Procedure: Sterile Normal Saline Infusion
Sterile Normal Saline Re-Suspension of cSVF and Delivery of AD-cSVF via IV route




Primary Outcome Measures :
  1. Number of participant with adverse events (AE) or severe adverse events (SAE) [ Time Frame: 6 month intervals for up to 5 years ]
    Activities of Daily Living (ADL)


Secondary Outcome Measures :
  1. Neurological Function [ Time Frame: 6 month Intervals for up to 5 years ]
    Change from baseline of deficits of neurologic function identified by patient as impaired prior to study

  2. Neurological Tested Functions [ Time Frame: 6 month interval for up to 5 years ]
    Change from baseline of deficits of neurological function identified by medical provider as impaired prior to study

  3. Magnetic Resonance Imaging (MRI) [ Time Frame: 6 month intervals for up to 5 years ]
    Change in baseline of MRI with and without contrast at 6 month intervals



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297177


Contacts
Contact: Ryan Welter, MD, PhD 508.345.5492 r.welter@regenerismedical.com
Contact: Kristin Corrado 508.316.4268 k.corrado@regenerismedical.com

Locations
United States, Massachusetts
Regeneris Medical Inc Recruiting
North Attleboro, Massachusetts, United States, 02760
Contact: Ryan Welter, MD, PhD    508-345-5492    r.welter@regenerismedical.com   
Contact: Kristin Corrado    508.316.4268    k.corrado@regenerismedical.com   
Principal Investigator: Ryan Welter, MD, PhD         
Principal Investigator: Robert W Alexander, MD         
Principal Investigator: Glenn C Terry, MD         
Regeneris Medical Recruiting
North Attleboro, Massachusetts, United States, 02760
Contact: Ryan Welter, MD, PhD    508-316-4268    k.corrado@regenerismedical.com   
Contact: Kristin Corrado    508.316.4268    k.corrado@regenerismedical.com   
Principal Investigator: Glenn C Terry, MD         
Principal Investigator: Robert W Alexander, MD         
Principal Investigator: Ryan Welter, MD, PhD         
Sponsors and Collaborators
Regeneris Medical
Global Alliance for Regenerative Medicine
Robert W. Alexander, MD, FICS
Regeneris Medical Inc
Investigators
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

Publications:

Responsible Party: Ryan Welter, MD, PhD, Principal Investigator, Science, Healeon Medical Inc
ClinicalTrials.gov Identifier: NCT03297177     History of Changes
Other Study ID Numbers: GARM NDD
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Annual Summary of Enrolled Cases By All collaborators, principle investigators, or accept sub-investigators

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Alzheimer Disease
Autoimmune Diseases
Demyelinating Autoimmune Diseases, CNS
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Immune System Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Dementia
Tauopathies
Leukoencephalopathies