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

NCT02939859 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-02-16

No results posted yet for this study

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

Interventions

PROCEDURE

Microcannula Harvest Adipose

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

DEVICE

Centricyte 1000

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

PROCEDURE

Sterile Normal Saline IV deployment AD-cSVF

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

Sponsors & Collaborators

  • Global Alliance for Regenerative Medicine

    collaborator OTHER

  • Healeon Medical Inc

    lead INDUSTRY

Principal Investigators

  • Robert W Alexander, MD · GARM International

  • Glenn C Terry, MD · GARM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-15
Primary Completion
2022-10-31
Completion
2023-10-31
FDA Drug
Yes

Countries

  • United States
  • Honduras

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02939859 on ClinicalTrials.gov