protocolSection identificationModule nctId: NCT06354023, orgStudyIdInfo id: IAGH for Osteoarthritis, briefTitle: Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2025-05-08, completionDateStruct date: 2025-05-08, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: John Sledge, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Osteoarthritis, Knee, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The proposed clinical trial is a single-arm intervention model. Once per week for six weeks, each participant will receive an intra-articular injection of recombinant human growth hormone (rGH) 15 IU in their affected knee. During the treatment course, the participants will use the same knee brace and crutches (as needed) and be given the same exercises to complete at home. They will all be evaluated 8 weeks, 6 months, and 12 months after their initial injection., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: None, each participant will receive the same treatment, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant human growth hormone, outcomesModule primaryOutcomes measure: Knee Society Score, primaryOutcomes measure: Kellgren-Lawrence Grading Scale, secondaryOutcomes measure: Serum IGF-1 Levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 72 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: BioShift Life Sciences, city: Santa Monica, state: California, zip: 90404, country: United States, contacts name: Maggie Phillips, role: CONTACT, phone: 301-655-4651, email: maggie@bioshift.com, geoPoint lat: 34.01945, lon: -118.49119, hasResults: False