Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis

Paused · Phase 2

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT06354023

Run by

John Sledge

People needed

23

Starts

2025-02-08

Expected to finish

2026-02-08

Last updated by the study team

2024-10-04

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Should be between 18-72 years old
• Can comply with partial weight-bearing status during the study
• Should have symptomatic knee arthritis
• Knee pain ≥3 months
• Kellgren-Lawrence score between 1-3
• Should have complete blood count levels within healthy ranges
• Should have complete renal function based on the metabolic panel
• Should have IGF-1 levels within the designated healthy range for their age
• Should have normal thyroid function

You may not qualify if…

• Should not have a current or previous cancer diagnosis
• Should not have rheumatoid arthritis
• Should not have hemophilia
• Should not abnormal knee alignment or stability
• Should not be pregnant or trying to get pregnant
• Should not have had a knee injection within the last 3 months
• Should not have a history of drug or alcohol abuse
• Should not have a diabetes diagnosis
• Should not have inflammatory or septic knee arthritis
• Should not have any signs of infection
• Should not have used anti-coagulants and/or NSAIDs 7 days before treatment begins

Where it is running

• BioShift Life Sciences — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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