Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354023
Status:
SUSPENDED
Last Update Posted:
2024-04-17
First Post:
2024-04-03
Brief Title:
Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis
Sponsor:
John Sledge
Organization:
BioShift Life Sciences
Study Overview
Official Title:
Administration of Recombinant Human Growth Hormone in the Knee Joint of Patients Suffering from Osteoarthritis
Status:
SUSPENDED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study has been placed on a clinical hold by the FDA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 participants treated knee
Does the participant have more mobility after the injections
The physician will monitor the participants 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
Do growth hormone injections in the knee joint stimulate cartilage growth
Do the injections lower pain and stiffness in the participants treated knee
Does the participant have more mobility after the injections
The physician will monitor the participants 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 participants 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 participants 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 patients 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 participants 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 005
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
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 participants 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 participants 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 patients 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 participants 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 005
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None