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Evaluation of Safety and Efficacy of Wharton's Jelly Compared to Hyaluronic Acid and Saline for Knee Osteoarthritis.

NCT04711304 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2022-07-21

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and efficacy of intraarticular injection of umbilical cord derived Wharton's Jelly compared to hyaluronic acid and saline for treatment of knee osteoarthritis symptoms.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

Umbilical Cord-derived Wharton's Jelly

Intraarticular injection

DEVICE

Hyaluronic acid

Intraarticular injection

OTHER

Saline

Intraarticular injection

Sponsors & Collaborators

  • BioIntegrate

    lead INDUSTRY

Principal Investigators

  • Saadiq F. El-Amin III, MD, PhD · El-Amin Orthopaedic & Sports Medicine Institute

  • Ashim Gupta, PhD, MBA · BioIntegrate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2026-06-01
Completion
2026-06-01

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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 NCT04711304 on ClinicalTrials.gov