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Hormone Therapy

Intra-articular Injection of Recombinant Human Growth Hormone for Osteoarthritis

Phase 2

Waitlist Available

Led By John Sledge, MD

Research Sponsored by John Sledge

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the grade will be assigned at 3 time points: before the first injection, immediately before the 6th injection, and one hour after the 6th injection.

Awards & highlights

Study Summary

This trial aims to test if growth hormone injections can help treat knee osteoarthritis. The injections may stimulate cartilage growth, reduce pain and stiffness, and improve mobility in the knee. Participants will

Who is the study for?

This trial is for individuals with osteoarthritis in the knee. Participants should be willing to receive weekly growth hormone injections directly into their knee joint over a six-week period and follow up with exercises, X-rays, and clinic visits.Check my eligibility

What is being tested?

The study tests if injecting human growth hormone into the knee stimulates cartilage growth, reduces pain and stiffness, and improves mobility. Progress is monitored through X-rays, physical evaluations, questionnaires on treatment effects.See study design

What are the potential side effects?

Potential side effects may include discomfort at injection site, swelling or stiffness in the treated knee. Since it's an investigational treatment, other unexpected side effects could occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the grade will be assigned at 3 time points: before the first injection, immediately before the 6th injection, and one hour after the 6th injection.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the grade will be assigned at 3 time points: before the first injection, immediately before the 6th injection, and one hour after the 6th injection.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the grade will be assigned at 3 time points: before the first injection, immediately before the 6th injection, and one hour after the 6th injection. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Kellgren-Lawrence Grading Scale

Knee Society Score

Secondary outcome measures

Serum IGF-1 Levels

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intra-articular Injection of Recombinant Human Growth HormoneExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Recombinant human growth hormone

2003

Completed Phase 4

~210

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

John SledgeLead Sponsor

John Sledge, MDPrincipal InvestigatorBioShift Life Sciences

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for participants in this research study?

"Information available on clinicaltrials.gov indicates that recruitment for this trial is closed. The posting date was May 8, 2024, with the last update made on April 3, 2024. While this study is no longer enrolling participants, there are currently 655 other trials open for enrollment."

Answered by AI

Are individuals younger than 20 years old eligible to participate in this clinical study?

"To be eligible for participation in this research, individuals must fall within the age range of 18 to 72 years. Notably, there are 32 trials catering to minors under 18 and another set of studies comprising 616 trials specifically designed for participants over the age of 65."

Answered by AI

Has the FDA authorized the use of recombinant human growth hormone through injection into joints?

"Our group at Power evaluated the safety of Intra-articular Injection of Recombinant Human Growth Hormone as a 2 on our scale due to being in Phase 2, signifying existing safety data with no evidence yet supporting efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis

John Sledge 2024. "Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06354023.

All > Osteoarthritis Knee