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Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries

NCT02959294 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2021-02-16

No results posted yet for this study

Summary

Concussion is the most common type of brain injury throughout life. Study is seeking improvement of long-term residua following adolescent and adult post-traumatic injuries often associated with contact sports and accidental causes. Typically defined as reversible head injury with temporary loss of brain function. Symptoms range from physical, cognitive, pain (headache) and emotional signs consistent with TBI and Post-Traumatic Stress Syndrome. Use of AD-cSVF parenteral delivery to encourage repair of damage and decreased function following concussion, particularly in contact, repetitive sports injuries. Range of damage is measured in Grade I-III according to graduated severity. Unfortunately, less information is available about repetitive concussions and the long-term health issues.

Conditions

  • Traumatic Encephalopathies, Chronic
  • Concussion, Mild
  • Concussion, Intermediate
  • Concussion, Severe
  • Concussion, Brain

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 Autologous AD-tSVF to create AD-cSVF

PROCEDURE

Sterile Normal Saline IV deployment AD-cSVF

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

Sponsors & Collaborators

  • Robert W. Alexander, MD, FICS

    lead INDUSTRY

Principal Investigators

  • Robert W. Alexander, MD · GARM International and GARM USA

  • Glenn C Terry, MD · GARM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2023-11-30
Completion
2024-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02959294 on ClinicalTrials.gov