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Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis

NCT06354023 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-10-04

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Recombinant human growth hormone

All participants will receive six weeks of treatment. Once per week, they will receive one intra-articular injection of 2cc (15IU) recombinant human growth hormone in their affected knee. The injection will also contain 1cc (1%) Lidocaine and 1cc (0.5%) Marcaine and Epinephrine for anesthetic purposes. The participants will receive a total of 6 growth hormone injections.

Sponsors & Collaborators

  • John Sledge

    lead OTHER

Principal Investigators

  • John Sledge, MD · BioShift Life Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-08
Primary Completion
2026-02-08
Completion
2026-02-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06354023 on ClinicalTrials.gov