Osteoarthritis, KneePhase 2NCT06354023
Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis
A Phase 2 study testing Recombinant human growth hormone in people with Osteoarthritis, Knee, run by John Sledge at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Recombinant human growth hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2025to 8 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
BioShift Life Sciences
Santa Monica, California, 90404
About this study
Official title: Administration of Recombinant Human Growth Hormone in the Knee Joint of Patients Suffering from Osteoarthritis
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?
Read more
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.
Read the detailed description
The trial and protocol are being reviewed by PearlIRB, an institutional review board, at 29 East McCarty St, Suite #100, Indianapolis, IN 46225.
Clinical and non-clinical studies of repeated intra-articular human growth hormone injections have shown to regrow cartilage and reduce symptoms of osteoarthritis (OA). Recently, a population of stem cells, osteochondroreticular (OCR) stem cells, were identified in adult mice. OCR stem cells were found to display growth hormone (GH) receptors and can undergo asymmetric division. The cells respond to GH in a paracrine-like manner with insulin-like growth factor 1 (IGF-1) and have been found to differentiate into chondrocytes on the articular surfaces of mice. Chondrocytes have been shown to have few if any, GH receptors, so it is likely that the OCR cells are the target of GH and are responsible for the treatment effect. It is hypothesized that the weekly injections of recombinant human growth hormone (rGH) into the knee joint of patients suffering from OA will act upon chondrocyte progenitor cells to divide and release IGF-1 that will act in a paracrine manner and promote the formation of new hyaline cartilage in the joint capsule.
People with OA will be recruited through the participating physicians, friends, and family of the clinic, and word of mouth. Participants will be identified based on physician assessment of the inclusion and exclusion criteria. After discussing the purpose of the study, if the patient wishes to participate, they will read and sign the informed consent form, acknowledging they understand the trial they are participating in. The participants will undergo a blood draw to ensure they meet the inclusion criteria in the study. When the participant's blood work has been completed and if the levels fall within the ranges of the study, the patient will have preliminary X-ray images taken of their affected knee.
The participant's knee will be assessed by a physician using the Knee Society Score and the Kellgren-Lawrence grading scale. The participant and physician complete the Knee Society Score form. The questionnaire is scored out of 100 possible points; the higher the score, the less severe a patient's OA. The Kellgren-Lawrence scale is a 0 (no signs of OA) to 4 (severe OA) grading system that uses radiographs of the knee to evaluate the severity of OA. Due to low intra- and interobserver reliability, automated imaging software will be used to analyze changes in each participant's radiographs.
The treatment plan for each participant will involve a weekly intra-articular injection of 15IU rGH with Lidocaine and Marcaine for a duration of 6 weeks. Participants will have crutches and be weight-bearing as tolerated during the treatment. To monitor the progress, X-ray images of the treated knee will be taken before the first injection, 8 weeks after the initial injection, and at 6 and 12 months after the initial injection. Additional blood draws will be conducted immediately before the 6th injection and in the afternoon after the 6th injection to evaluate circulating IGF-1 levels. The physician will assess the injected knee using the Knee Society Score and the Kellgren-Lawrence grading scale before treatment begins and at 8 weeks, 6 months, and 12 months after the initial injection.
The study will have 23 subjects, and we hope that this is enough to allow us to reject our null hypothesis. The trial is constrained to some degree by the cost of the growth hormone.
The source documents will be the Knee Society Score questionnaire and the Kellgren-Lawrence grade that will be determined by automated radiographic classifiers. The two tests will be evaluated using a one-tailed t-test to determine significance between the different time periods with a p-value < 0.05.
Patient safety data will be presented as a combination of patient-reported safety, physician-reported patient safety, and any adverse events (AE) or serious adverse events (SAE) as reported by the physicians. All AE and SAE will be collected and submitted to the PI at the time of their identification. All submissions will be acknowledged within 24 hours. All submissions will have an association determination within 72 hours by Dr. John Sledge. Any life-threatening event that is determined to be related or possibly related to the study will be seen as potential grounds for study termination. Any Unanticipated Problem will be seen as potential grounds for study termination.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Recombinant human growth hormone
- Keywords
- Intra-Articular Injection, Somatropin, Growth Hormone
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human growth hormoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular Injection of Recombinant Human Growth Hormone | Experimental | Not described Receives: Drug: Recombinant human growth hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
A blood test to identify circulating insulin-like growth factor 1 (IGF-1) levels. The levels will be an indicator of growth hormone leakage from the joint capsule.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start8 Feb 2025 (estimated)
- Primary completion8 Feb 2026 (estimated)
- Study completion8 Feb 2026 (estimated)
Why it stopped: The study has been placed on a clinical hold by the FDA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Sledge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Sledge, BioShift Life Sciences
- Investigators
- John Sledge, MD, Principal investigator, BioShift Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354023
- Sponsor's protocol ID
- IAGH for Osteoarthritis
- Status last verified
- Aug 2024
- First submitted
- 3 Apr 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This study proposes to share data but only when the names and identifying characteristics have been removed. The only data that will be shared will be the questionnaire results or changes in the Kellgren-Lawrence grading scale.
Publications
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.
PubMed 24453578Imani 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.
PubMed 34150571Rahimzadeh 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.
PubMed 28975078Thomas 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.
PubMed 32280948Worthley 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.
PubMed 25594183
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Recombinant Human Growth Hormone in the Knee Joint of Patients Suffering from Osteoarthritis
- ClinicalTrials.gov ID
- NCT06354023
- Acronym / sponsor ID
- IAGH for Osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Keywords
- Intra-Articular Injection, Somatropin, Growth Hormone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study has been placed on a clinical hold by the FDA.
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- John SledgeUniversity, hospital or other
- Study start
- 8 Feb 2025 (estimated)
- Primary completion
- 8 Feb 2026 (estimated)
- Study completion
- 8 Feb 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial and protocol are being reviewed by PearlIRB, an institutional review board, at 29 East McCarty St, Suite #100, Indianapolis, IN 46225.
Clinical and non-clinical studies of repeated intra-articular human growth hormone injections have shown to regrow cartilage and reduce symptoms of osteoarthritis (OA). Recently, a population of stem cells, osteochondroreticular (OCR) stem cells, were identified in adult mice. OCR stem cells were found to display growth hormone (GH) receptors and can undergo asymmetric division. The cells respond to GH in a paracrine-like manner with insulin-like growth factor 1 (IGF-1) and have been found to differentiate into chondrocytes on the articular surfaces of mice. Chondrocytes have been shown to have few if any, GH receptors, so it is likely that the OCR cells are the target of GH and are responsible for the treatment effect. It is hypothesized that the weekly injections of recombinant human growth hormone (rGH) into the knee joint of patients suffering from OA will act upon chondrocyte progenitor cells to divide and release IGF-1 that will act in a paracrine manner and promote the formation of new hyaline cartilage in the joint capsule.
People with OA will be recruited through the participating physicians, friends, and family of the clinic, and word of mouth. Participants will be identified based on physician assessment of the inclusion and exclusion criteria. After discussing the purpose of the study, if the patient wishes to participate, they will read and sign the informed consent form, acknowledging they understand the trial they are participating in. The participants will undergo a blood draw to ensure they meet the inclusion criteria in the study. When the participant's blood work has been completed and if the levels fall within the ranges of the study, the patient will have preliminary X-ray images taken of their affected knee.
The participant's knee will be assessed by a physician using the Knee Society Score and the Kellgren-Lawrence grading scale. The participant and physician complete the Knee Society Score form. The questionnaire is scored out of 100 possible points; the higher the score, the less severe a patient's OA. The Kellgren-Lawrence scale is a 0 (no signs of OA) to 4 (severe OA) grading system that uses radiographs of the knee to evaluate the severity of OA. Due to low intra- and interobserver reliability, automated imaging software will be used to analyze changes in each participant's radiographs.
The treatment plan for each participant will involve a weekly intra-articular injection of 15IU rGH with Lidocaine and Marcaine for a duration of 6 weeks. Participants will have crutches and be weight-bearing as tolerated during the treatment. To monitor the progress, X-ray images of the treated knee will be taken before the first injection, 8 weeks after the initial injection, and at 6 and 12 months after the initial injection. Additional blood draws will be conducted immediately before the 6th injection and in the afternoon after the 6th injection to evaluate circulating IGF-1 levels. The physician will assess the injected knee using the Knee Society Score and the Kellgren-Lawrence grading scale before treatment begins and at 8 weeks, 6 months, and 12 months after the initial injection.
The study will have 23 subjects, and we hope that this is enough to allow us to reject our null hypothesis. The trial is constrained to some degree by the cost of the growth hormone.
The source documents will be the Knee Society Score questionnaire and the Kellgren-Lawrence grade that will be determined by automated radiographic classifiers. The two tests will be evaluated using a one-tailed t-test to determine significance between the different time periods with a p-value < 0.05.
Patient safety data will be presented as a combination of patient-reported safety, physician-reported patient safety, and any adverse events (AE) or serious adverse events (SAE) as reported by the physicians. All AE and SAE will be collected and submitted to the PI at the time of their identification. All submissions will be acknowledged within 24 hours. All submissions will have an association determination within 72 hours by Dr. John Sledge. Any life-threatening event that is determined to be related or possibly related to the study will be seen as potential grounds for study termination. Any Unanticipated Problem will be seen as potential grounds for study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intra-articular Injection of Recombinant Human Growth Hormone | Experimental | Drug: Recombinant human growth hormone |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Should be between 18-72 years old
- Can comply with partial weight-bearing status during the study
- Should have symptomatic knee arthritis
- Should have complete blood count levels within healthy ranges
- Should have complete renal function based on the metabolic panel
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human growth hormoneAll 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. | Drug | Intra-articular Injection of Recombinant Human Growth Hormone |
Primary outcome
Knee Society Score
Time frame: 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.
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.
Kellgren-Lawrence Grading Scale
Time frame: 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.
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.
1 secondary outcome
Serum IGF-1 Levels
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 24453578Martimbianco 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.
- Background: PubMed 34150571Imani 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.
- Background: PubMed 28975078Rahimzadeh 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.
- Background: PubMed 32280948Thomas 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.
- Background: PubMed 25594183Worthley 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.
- Individual participant dataSharing planned: No. This study proposes to share data but only when the names and identifying characteristics have been removed. The only data that will be shared will be the questionnaire results or changes in the Kellgren-Lawrence grading scale.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Sledge, MD principal investigator
BioShift Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human growth hormone in people with Osteoarthritis, Knee, run by John Sledge at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Score (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06354023, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.