Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile |
1 week |
|
| Primary |
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile |
6 weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile |
3 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile |
6 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile |
12 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Creatinine levels |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels |
1 Week |
|
| Primary |
Treatment-emergent adverse effects as assessed by Creatinine levels |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels |
6 Weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by Creatinine levels |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels |
3 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Creatinine levels |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels |
6 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Creatinine levels |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels |
12 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Liver Function Test |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test |
1 Week |
|
| Primary |
Treatment-emergent adverse effects as assessed by Liver Function Test |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test |
6 Weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by Liver Function Test |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test |
3 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Liver Function Test |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test |
6 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Liver Function Test |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test |
12 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Complete Blood Count |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count |
1 Week |
|
| Primary |
Treatment-emergent adverse effects as assessed by Complete Blood Count |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count |
6 Weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by Complete Blood Count |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count |
3 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Complete Blood Count |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count |
6 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Complete Blood Count |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count |
12 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by C-reactive protein |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein |
1 Week |
|
| Primary |
Treatment-emergent adverse effects as assessed by C-reactive protein |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein |
6 Weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by C-reactive protein |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein |
3 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by C-reactive protein |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein |
6 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by C-reactive protein |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein |
12 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate |
1 Week |
|
| Primary |
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate |
6 Weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate |
3 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate |
6 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate |
12 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets |
1 Week |
|
| Primary |
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets |
6 Weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets |
3 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets |
6 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets |
12 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels |
1 Week |
|
| Primary |
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels |
6 Weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels |
3 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels |
6 Months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels |
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels |
12 Months |
|
| Secondary |
Change in patient reported outcome measures, Numeric Pain Rating Scale |
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement. |
Change from baseline to immediately after injection |
|
| Secondary |
Change in patient reported outcome measures, Numeric Pain Rating Scale |
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement. |
Change from baseline to 24 hours after injection |
|
| Secondary |
Change in patient reported outcome measures, Numeric Pain Rating Scale |
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement. |
Change from baseline to 48 hours after injection |
|
| Secondary |
Change in patient reported outcome measures, Numeric Pain Rating Scale |
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement. |
Change from baseline to 1 week after injection |
|
| Secondary |
Change in patient reported outcome measures, Numeric Pain Rating Scale |
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement. |
Change from baseline to 6 weeks after injection |
|
| Secondary |
Change in patient reported outcome measures, Numeric Pain Rating Scale |
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement. |
Change from baseline to 3 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Numeric Pain Rating Scale |
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement. |
Change from baseline to 6 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Numeric Pain Rating Scale |
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement. |
Change from baseline to 12 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Numeric Pain Rating Scale |
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement. |
Change from baseline to 18 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Numeric Pain Rating Scale |
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement. |
Change from baseline to 24 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. |
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement. |
Change from baseline to 1 week after injection |
|
| Secondary |
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. |
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement. |
Change from baseline to 6 weeks after injection |
|
| Secondary |
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. |
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement. |
Change from baseline to 3 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. |
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement. |
Change from baseline to 6 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. |
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement. |
Change from baseline to 12 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. |
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement. |
Change from baseline to 18 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr. |
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement. |
Change from baseline to 24 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. |
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement. |
Change from baseline to 1 week after injection |
|
| Secondary |
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. |
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement. |
Change from baseline to 6 weeks after injection |
|
| Secondary |
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. |
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement. |
Change from baseline to 3 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. |
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement. |
Change from baseline to 6 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. |
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement. |
Change from baseline to 12 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. |
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement. |
Change from baseline to 18 months after injection |
|
| Secondary |
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score. |
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement. |
Change from baseline to 24 months after injection |
|
| Secondary |
Patient Satisfaction via 5-point Likert Scale |
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement. |
1 Week after injection |
|
| Secondary |
Patient Satisfaction via 5-point Likert Scale |
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement. |
6 Weeks after injection |
|
| Secondary |
Patient Satisfaction via 5-point Likert Scale |
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement. |
3 Months after injection |
|
| Secondary |
Patient Satisfaction via 5-point Likert Scale |
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement. |
6 Months after injection |
|
| Secondary |
Patient Satisfaction via 5-point Likert Scale |
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement. |
12 Months after injection |
|
| Secondary |
Patient Satisfaction via 5-point Likert Scale |
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement. |
18 Months after injection |
|
| Secondary |
Patient Satisfaction via 5-point Likert Scale |
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement. |
24 Months after injection |
|
| Secondary |
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) |
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement. |
Change from baseline to 1 week after injection |
|
| Secondary |
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) |
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement. |
Change from baseline to 6 weeks after injection |
|
| Secondary |
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) |
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement. |
Change from baseline to 3 months after injection |
|
| Secondary |
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) |
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement. |
Change from baseline to 6 months after injection |
|
| Secondary |
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) |
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement. |
Change from baseline to 12 months after injection |
|
| Secondary |
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) |
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement. |
Change from baseline to 18 months after injection |
|
| Secondary |
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE) |
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement. |
Change from baseline to 24 months after injection |
|
| Secondary |
Patient Satisfaction via 36-item short form survey (SF36) |
To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement. |
Change from baseline to 3 months after injection |
|
| Secondary |
Patient Satisfaction via 36-item short form survey (SF36) |
To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement. |
Change from baseline to 6 months after injection |
|
| Secondary |
Patient Satisfaction via 36-item short form survey (SF36) |
To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement. |
Change from baseline to 12 months after injection |
|
| Secondary |
Patient Satisfaction via 36-item short form survey (SF36) |
To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement. |
Change from baseline to 18 months after injection |
|
| Secondary |
Patient Satisfaction via 36-item short form survey (SF36) |
To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement. |
Change from baseline to 24 months after injection |
|
| Secondary |
Cartilage Formation |
To assess cartilage formation via MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue). An increase in score indicates improvement. |
Change from baseline to 12 months after injection |
|
| Secondary |
Cartilage Formation |
To assess cartilage formation via MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue). An increase in score indicates improvement. |
Change from baseline to 24 months after injection |
|
