MedTrace Logo

Stem Cell and Growth Factor Injury and Arthritis Clinical Research Study

NCT03408145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-03-25

No results posted yet for this study

Summary

The investigators believe that amniotic tissue allografts may be an effective modality to treat osteoarthritis (OA) of the knee. One important mechanism of action may be stimulation of the synovial cells to increase production of endogenous hyaluronic acid (HA). A second mechanism may be the increase in the anabolic factors and a decrease in degenerative factors in the joint. The Investigators propose to quantify the concentration of HA and selected anabolic and degradative factors in synovial fluid aspirate pre and post implantation. While the treatment provided is designed to provide pain relief for symptoms, the purpose of this study is to learn more information about the impact of amniotic tissue allografts on inflammatory markers and growth factors in the knee joint.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Hyaluronic Acid

Injection of 3x 2.5ml of Hyaluronic Acid

DEVICE

Amniotic Tissue Allograft

Injection of 1x 1ml of Amniotic Tissue Allograft

DRUG

Saline

Injection of Saline

Sponsors & Collaborators

  • The Stone Research Foundation for Sports Medicine and Arthritis

    lead OTHER

Principal Investigators

  • Kevin R Stone, MD · The Foundation for Sports Medicine and Arthritis Research (Stone Research Foundation)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-04
Primary Completion
2019-10-10
Completion
2020-10-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03408145 on ClinicalTrials.gov