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NCT06354023Not yet recruiting

Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis

Administration of Recombinant Human Growth Hormone in the Knee Joint of Patients Suffering From Osteoarthritis
John SledgePhase 2ClinicalTrials.govdrug
Study focus
Disease/Condition
Osteoarthritis, Knee
Drug/Device/Intervention
Recombinant human growth hormone
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
John Sledge
Funder
BioShift Life Sciences
Location
Santa Monica, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
May 08, 2024
End date
May 08, 2025
Enrollment
23 participants
Primary outcome

Knee Society Score,Kellgren-Lawrence Grading Scale

Summary

The goal of this clinical trial is to learn if growth hormone injections can be used to treat
 osteoarthritis (OA) in the knee. Human studies have shown that repeated injections of human
 growth hormone leads to the production of articular chondrocytes, which are the cells that
 make up the cartilage in the knee joint. Restoring cartilage in the knee can alleviate pain,
 improve function, and postpone the need for a joint replacement procedure. The main questions
 the study aims to answer are:
 
 - Do growth hormone injections in the knee joint stimulate cartilage growth?
 
 - Do the injections lower pain and stiffness in the participant's treated knee?
 
 - Does the participant have more mobility after the injections?
 
 The physician will monitor the participant's progress through X-ray images, questionnaires,
 and physical evaluation of the treated knee.
 
 For the trial, participants will:
 
 - Receive a growth hormone injection in their knee once per week for six weeks, for a
 total of 6 injections.
 
 - Complete at-home exercises during the treatment period.
 
 - Use crutches as needed during the trial.
 
 - Have X-rays taken at 8 weeks, 6 months, and 12 months after the first injection.
 
 - Go to follow-up visits at 8 weeks, 6 months, and 12 months after the first injection.
 
 - Complete treatment surveys before treatment starts and after it is finished.

ICD-10 classifications
Chronic instability of kneeInjuries to the knee and lower legGonarthrosis [arthrosis of knee]Dislocation, sprain and strain of joints and ligaments of kneeSprain and strain of other and unspecified parts of knee
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06354023
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06354023 through Pure Global AI's free database. This Phase 2 trial is sponsored by John Sledge and is currently Not yet recruiting. The study focuses on Osteoarthritis, Knee. Target enrollment is 23 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.