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Cell-free Stem Cell-derived Extract Formulation for Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04971798
Recruitment Status : Not yet recruiting
First Posted : July 21, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
General Therapeutics

Brief Summary:
The purpose of this study is to determine the safety and efficacy of intraarticular injection of Cell-free Stem Cell-derived Extract Formulation for treatment of knee osteoarthritis symptoms.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: Cell-free Stem Cell-derived Extract Formulation (CCM) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non-randomized, Open-label, Multi-center, Prospective Study to Evaluate the Safety and Efficacy of Intraarticular Injection of Cell-free Stem Cell-derived Extract Formulation in Patients Suffering From Knee Osteoarthritis
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Cell-free Stem cell-derived Extract Formulation (CCM)
Intraarticular administration of CCM
Biological: Cell-free Stem Cell-derived Extract Formulation (CCM)
Intraarticular injection




Primary Outcome Measures :
  1. Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile [ Time Frame: 1 week ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile

  2. Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile [ Time Frame: 6 weeks ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile

  3. Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile [ Time Frame: 3 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile

  4. Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile [ Time Frame: 6 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile

  5. Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile [ Time Frame: 12 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile

  6. Treatment-emergent adverse effects as assessed by Creatinine levels [ Time Frame: 1 Week ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels

  7. Treatment-emergent adverse effects as assessed by Creatinine levels [ Time Frame: 6 Weeks ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels

  8. Treatment-emergent adverse effects as assessed by Creatinine levels [ Time Frame: 3 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels

  9. Treatment-emergent adverse effects as assessed by Creatinine levels [ Time Frame: 6 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels

  10. Treatment-emergent adverse effects as assessed by Creatinine levels [ Time Frame: 12 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels

  11. Treatment-emergent adverse effects as assessed by Liver Function Test [ Time Frame: 1 Week ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test

  12. Treatment-emergent adverse effects as assessed by Liver Function Test [ Time Frame: 6 Weeks ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test

  13. Treatment-emergent adverse effects as assessed by Liver Function Test [ Time Frame: 3 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test

  14. Treatment-emergent adverse effects as assessed by Liver Function Test [ Time Frame: 6 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test

  15. Treatment-emergent adverse effects as assessed by Liver Function Test [ Time Frame: 12 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test

  16. Treatment-emergent adverse effects as assessed by Complete Blood Count [ Time Frame: 1 Week ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count

  17. Treatment-emergent adverse effects as assessed by Complete Blood Count [ Time Frame: 6 Weeks ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count

  18. Treatment-emergent adverse effects as assessed by Complete Blood Count [ Time Frame: 3 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count

  19. Treatment-emergent adverse effects as assessed by Complete Blood Count [ Time Frame: 6 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count

  20. Treatment-emergent adverse effects as assessed by Complete Blood Count [ Time Frame: 12 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count

  21. Treatment-emergent adverse effects as assessed by C-reactive protein [ Time Frame: 1 Week ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein

  22. Treatment-emergent adverse effects as assessed by C-reactive protein [ Time Frame: 6 Weeks ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein

  23. Treatment-emergent adverse effects as assessed by C-reactive protein [ Time Frame: 3 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein

  24. Treatment-emergent adverse effects as assessed by C-reactive protein [ Time Frame: 6 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein

  25. Treatment-emergent adverse effects as assessed by C-reactive protein [ Time Frame: 12 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein

  26. Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate [ Time Frame: 1 Week ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate

  27. Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate [ Time Frame: 6 Weeks ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate

  28. Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate [ Time Frame: 3 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate

  29. Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate [ Time Frame: 6 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate

  30. Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate [ Time Frame: 12 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate

  31. Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets [ Time Frame: 1 Week ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets

  32. Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets [ Time Frame: 6 Weeks ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets

  33. Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets [ Time Frame: 3 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets

  34. Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets [ Time Frame: 6 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets

  35. Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets [ Time Frame: 12 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets

  36. Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels [ Time Frame: 1 Week ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels

  37. Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels [ Time Frame: 6 Weeks ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels

  38. Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels [ Time Frame: 3 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels

  39. Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels [ Time Frame: 6 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels

  40. Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels [ Time Frame: 12 Months ]
    To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels


Secondary Outcome Measures :
  1. Change in patient reported outcome measures, Numeric Pain Rating Scale [ Time Frame: Change from baseline to immediately after injection ]
    To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.

  2. Change in patient reported outcome measures, Numeric Pain Rating Scale [ Time Frame: Change from baseline to 24 hours after injection ]
    To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.

  3. Change in patient reported outcome measures, Numeric Pain Rating Scale [ Time Frame: Change from baseline to 48 hours after injection ]
    To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.

  4. Change in patient reported outcome measures, Numeric Pain Rating Scale [ Time Frame: Change from baseline to 1 week after injection ]
    To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.

  5. Change in patient reported outcome measures, Numeric Pain Rating Scale [ Time Frame: Change from baseline to 6 weeks after injection ]
    To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.

  6. Change in patient reported outcome measures, Numeric Pain Rating Scale [ Time Frame: Change from baseline to 3 months after injection ]
    To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.

  7. Change in patient reported outcome measures, Numeric Pain Rating Scale [ Time Frame: Change from baseline to 6 months after injection ]
    To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.

  8. Change in patient reported outcome measures, Numeric Pain Rating Scale [ Time Frame: Change from baseline to 12 months after injection ]
    To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.

  9. Change in patient reported outcome measures, Numeric Pain Rating Scale [ Time Frame: Change from baseline to 18 months after injection ]
    To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.

  10. Change in patient reported outcome measures, Numeric Pain Rating Scale [ Time Frame: Change from baseline to 24 months after injection ]
    To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.

  11. Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. [ Time Frame: Change from baseline to 1 week after injection ]
    To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.

  12. Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. [ Time Frame: Change from baseline to 6 weeks after injection ]
    To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.

  13. Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. [ Time Frame: Change from baseline to 3 months after injection ]
    To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.

  14. Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. [ Time Frame: Change from baseline to 6 months after injection ]
    To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.

  15. Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. [ Time Frame: Change from baseline to 12 months after injection ]
    To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.

  16. Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. [ Time Frame: Change from baseline to 18 months after injection ]
    To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.

  17. Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. [ Time Frame: Change from baseline to 24 months after injection ]
    To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.

  18. Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. [ Time Frame: Change from baseline to 1 week after injection ]
    To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.

  19. Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. [ Time Frame: Change from baseline to 6 weeks after injection ]
    To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.

  20. Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. [ Time Frame: Change from baseline to 3 months after injection ]
    To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.

  21. Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. [ Time Frame: Change from baseline to 6 months after injection ]
    To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.

  22. Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. [ Time Frame: Change from baseline to 12 months after injection ]
    To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.

  23. Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. [ Time Frame: Change from baseline to 18 months after injection ]
    To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.

  24. Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. [ Time Frame: Change from baseline to 24 months after injection ]
    To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.

  25. Patient Satisfaction via 5-point Likert Scale [ Time Frame: 1 Week after injection ]
    To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.

  26. Patient Satisfaction via 5-point Likert Scale [ Time Frame: 6 Weeks after injection ]
    To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.

  27. Patient Satisfaction via 5-point Likert Scale [ Time Frame: 3 Months after injection ]
    To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.

  28. Patient Satisfaction via 5-point Likert Scale [ Time Frame: 6 Months after injection ]
    To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.

  29. Patient Satisfaction via 5-point Likert Scale [ Time Frame: 12 Months after injection ]
    To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.

  30. Patient Satisfaction via 5-point Likert Scale [ Time Frame: 18 Months after injection ]
    To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.

  31. Patient Satisfaction via 5-point Likert Scale [ Time Frame: 24 Months after injection ]
    To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.

  32. Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) [ Time Frame: Change from baseline to 1 week after injection ]
    To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.

  33. Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) [ Time Frame: Change from baseline to 6 weeks after injection ]
    To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.

  34. Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) [ Time Frame: Change from baseline to 3 months after injection ]
    To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.

  35. Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) [ Time Frame: Change from baseline to 6 months after injection ]
    To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.

  36. Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) [ Time Frame: Change from baseline to 12 months after injection ]
    To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.

  37. Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) [ Time Frame: Change from baseline to 18 months after injection ]
    To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.

  38. Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) [ Time Frame: Change from baseline to 24 months after injection ]
    To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.

  39. Patient Satisfaction via 36-item short form survey (SF36) [ Time Frame: Change from baseline to 3 months after injection ]
    To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement.

  40. Patient Satisfaction via 36-item short form survey (SF36) [ Time Frame: Change from baseline to 6 months after injection ]
    To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement.

  41. Patient Satisfaction via 36-item short form survey (SF36) [ Time Frame: Change from baseline to 12 months after injection ]
    To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement.

  42. Patient Satisfaction via 36-item short form survey (SF36) [ Time Frame: Change from baseline to 18 months after injection ]
    To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement.

  43. Patient Satisfaction via 36-item short form survey (SF36) [ Time Frame: Change from baseline to 24 months after injection ]
    To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement.

  44. Cartilage Formation [ Time Frame: Change from baseline to 12 months after injection ]
    To assess cartilage formation via MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue). An increase in score indicates improvement.

  45. Cartilage Formation [ Time Frame: Change from baseline to 24 months after injection ]
    To assess cartilage formation via MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue). An increase in score indicates improvement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be 18 years of age or older at the time of enrollment
  2. Have a body mass index (BMI) of ≤ 35Kg/m2
  3. Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after thorough explanation of the subject's participation has been provided
  4. Be willing and capable of subjective evaluation, reading and understanding written questionnaires, and reading, understanding and signing the written informed consent
  5. Has been diagnosed with Mild to Moderate knee osteoarthritis (OA) in one knee only, with a Grade 2 or 3 on the Kellgren Lawrence (KL) grading scale
  6. Has an average knee pain intensity ≥ 6 of the Numerical Pain Rating Scale (NPRS); Scale 0 to 10
  7. Be willing to not take any knee symptom modifying drugs from baseline through the End of Study
  8. Be willing and able to comply with study-related requirements, procedures, and visits
  9. If female, sexually active, and of childbearing age, subject must be willing to use a reliable form of birth control throughout the duration of the study. If Male, sexually active with partners of childbearing age, must be willing to use contraceptive measures

Exclusion Criteria:

  1. Has taken any pain medications, including NSAIDs, within 15 days prior to the study injection date
  2. Current use of anticoagulants or history of regular use of anticoagulants
  3. History of addiction to dependency producing medications or history of a substance abuse (including alcohol and illicit drugs)
  4. Has mechanical knee symptoms consistent with extensive intraarticular pathology not amenable to injection therapy alone, including clinical or imaging evidence indicative of ACL, MCL, LCL, or meniscal pathology
  5. Has undergone intraarticular injection of any drug including but not limited to corticosteroids or viscosupplementation in the index knee in the last 3 months
  6. History of any type of surgery on the index knee
  7. History of traumatic injury to the index knee within the last 3 months
  8. Has planned elective knee surgery during the course of the study
  9. History of organ or hematologic transplantation
  10. History of rheumatoid arthritis or other autoimmune disorders
  11. History of immunosuppressive medication/treatment or cancer diagnosis within the last 5 years
  12. Current knee infection or history of using antibiotics for knee infection within the last 3 months
  13. Has participated in another clinical study or received treatment with any investigational product within 30 days of enrollment
  14. Is pregnant as determined by urine testing unless female subject is surgically sterile or post-menopausal
  15. Currently breastfeeding or desires to be pregnant during the course of the study
  16. Has contraindications to X-ray or MRI imaging
  17. Has a diagnosis of progressive neurological disease
  18. Has a diagnosis of an active psychological or psychiatric disorder
  19. Has pain in other area(s) and/or medical condition(s) that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of the study
  20. Has unresolved major issues of secondary gain (e.g., social, financial, or legal (e.g., worker's compensation claim)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04971798


Contacts
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Contact: Craig Cady, PhD 2174161497 cjcady@icloud.com

Sponsors and Collaborators
General Therapeutics
Investigators
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Study Director: Craig Cady, PhD General Therapeutics
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: General Therapeutics
ClinicalTrials.gov Identifier: NCT04971798    
Other Study ID Numbers: GT - 2021CCM/OA
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases