Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis

NCT06354023 | Suspended Phase 2 FDA Drug

• 1 other identifier: IAGH for Osteoarthritis
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intra-Articular Injection; Somatropin; Growth Hormone

Outcome Measures

Primary Outcomes (2)

• Knee Society Score

  A validated questionnaire completed by both the physician and patient to assess changes from the treatment. The physician will evaluate the alignment, instability, and range of motion of the participant's knee. The participant completes a self-evaluation of their pain level, knee function, and treatment expectations. Each answer contains a numerical value with a possible completed score of 100.

  The questionnaire will be filled out at 4 time points: before treatment begins and at 8 weeks, 6 months, and 12 months after the first injection.

• Kellgren-Lawrence Grading Scale

  The physician uses anterior/posterior knee radiographs to complete the Kellgren-Lawrence Grading scale. Each radiograph is assigned a value of 0 to 4, which correlates to an increase in OA severity. To decrease observer bias and variability, automated staging of osteoarthritis using deep neural networks will be used to analyze changes in each patient's radiographs. The software automatically detects variability in image contrast, joint size, joint location in the frame, and limb size.

  The grade will be assigned at 4 time points: before treatment begins and at 8 weeks, 6 months, and 12 months after the first injection.

Secondary Outcomes (1)

• Serum IGF-1 Levels

  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.

Study Arms (1)

Intra-articular Injection of Recombinant Human Growth Hormone

EXPERIMENTAL

Drug: Recombinant human growth hormone

Interventions

Recombinant human growth hormone DRUG

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.

Intra-articular Injection of Recombinant Human Growth Hormone

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• John Sledge: lead

Study Sites (1)

BioShift Life Sciences

Santa Monica, California, 90404, United States

Location

Related Publications (5)

• Martimbianco AL, Calabrese FR, Iha LA, Petrilli M, Lira Neto O, Carneiro Filho M. Reliability of the "American Knee Society Score" (AKSS). Acta Ortop Bras. 2012;20(1):34-8. doi: 10.1590/S1413-78522012000100007.

  PMID: 24453578 BACKGROUND

• Imani F, Hejazian K, Kazemi MR, Narimani-Zamanabadi M, Malik KM. Adding Ozone to Dextrose and Somatropin for Intra-articular Knee Prolotherapy: A Randomized Single-Blinded Controlled Trial. Anesth Pain Med. 2020 Nov 7;10(5):e110277. doi: 10.5812/aapm.110277. eCollection 2020 Oct.

  PMID: 34150571 BACKGROUND

• Rahimzadeh P, Imani F, Faiz SH, Alebouyeh MR, Azad-Ehyaei D, Bahari L, Memarian A, Kim KH. Adding Intra-Articular Growth Hormone to Platelet Rich Plasma under Ultrasound Guidance in Knee Osteoarthritis: A Comparative Double-Blind Clinical Trial. Anesth Pain Med. 2016 Oct 19;6(6):e41719. doi: 10.5812/aapm.41719. eCollection 2016 Dec.

  PMID: 28975078 BACKGROUND

• Thomas KA, Kidzinski L, Halilaj E, Fleming SL, Venkataraman GR, Oei EHG, Gold GE, Delp SL. Automated Classification of Radiographic Knee Osteoarthritis Severity Using Deep Neural Networks. Radiol Artif Intell. 2020 Mar 18;2(2):e190065. doi: 10.1148/ryai.2020190065.

  PMID: 32280948 BACKGROUND

• Worthley DL, Churchill M, Compton JT, Tailor Y, Rao M, Si Y, Levin D, Schwartz MG, Uygur A, Hayakawa Y, Gross S, Renz BW, Setlik W, Martinez AN, Chen X, Nizami S, Lee HG, Kang HP, Caldwell JM, Asfaha S, Westphalen CB, Graham T, Jin G, Nagar K, Wang H, Kheirbek MA, Kolhe A, Carpenter J, Glaire M, Nair A, Renders S, Manieri N, Muthupalani S, Fox JG, Reichert M, Giraud AS, Schwabe RF, Pradere JP, Walton K, Prakash A, Gumucio D, Rustgi AK, Stappenbeck TS, Friedman RA, Gershon MD, Sims P, Grikscheit T, Lee FY, Karsenty G, Mukherjee S, Wang TC. Gremlin 1 identifies a skeletal stem cell with bone, cartilage, and reticular stromal potential. Cell. 2015 Jan 15;160(1-2):269-84. doi: 10.1016/j.cell.2014.11.042.

  PMID: 25594183 BACKGROUND

Related Links

• Intra-articular growth hormone injections regrow cartilage, increase motion and reduce pain in 93 per cent. of arthritic ankles. Osteoarthritis and Cartilage, 20, S1-S296.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• John Sledge, MD

  BioShift Life Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: None, each participant will receive the same treatment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: February 8, 2025
• Primary Completion: February 8, 2026
• Study Completion: February 8, 2026
• Last Updated: October 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)