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Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis - Trial NCT06354023

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.

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NCT06354023
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06354023
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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

Study Focus

Osteoarthritis, Knee

Recombinant human growth hormone

Interventional

drug

Sponsor & Location

John Sledge

BioShift Life Sciences

Santa Monica, United States of America

Timeline & Enrollment

Phase 2

May 08, 2024

May 08, 2025

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 knee
Injuries to the knee and lower leg
Gonarthrosis [arthrosis of knee]
Dislocation, sprain and strain of joints and ligaments of knee
Sprain and strain of other and unspecified parts of knee

Data Source

ClinicalTrials.gov

NCT06354023

Non-Device Trial