Autologous Stem/Stromal Cells in Neurological Disorders and Disease

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.

Conditions

• Dementia
• Parkinson
• Altered Behavior in Alzheimer Disease
• Demyelinating Autoimmune Diseases, CNS
• Demyelinating Sensorimotor Neuropathy
• Corticobasal Degeneration

Interventions

PROCEDURE

Microcannula Harvest Adipose

Use Closed Syringe Microcannula Harvest Adipose, Autologous Subdermal Deposits

DEVICE

Centricyte 1000

Closed System, Digestive Isolation \& Concentration of AD-cSVF

PROCEDURE

Sterile Normal Saline Infusion

Sterile Normal Saline Re-Suspension of cSVF and Delivery of AD-cSVF via IV route

Sponsors & Collaborators

• Global Alliance for Regenerative Medicine

  collaborator OTHER

• Robert W. Alexander, MD, FICS

  collaborator UNKNOWN

• Regeneris Medical Inc

  collaborator UNKNOWN

• Regeneris Medical

  lead OTHER

Principal Investigators

• Ryan Welter, MD, PhD · Regeneris Medical Inc

• Glenn C Terry · Global Alliance for Regenerative Medicine (GARM)

• Robert W Alexander, MD · Healeon Medical

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2023-01-01

Completion

2023-01-01

FDA Device

Yes

Countries

• United States

Study Locations