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 Umbilical cord-derived Wharton's Jelly as assessed by Comprehensive metabolic profile |
1week |
|
| Primary |
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by Comprehensive metabolic profile |
6weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by Comprehensive metabolic profile |
3months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by Comprehensive metabolic profile |
6months |
|
| Primary |
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by Comprehensive metabolic profile |
1year |
|
| Primary |
Treatment-emergent adverse effects as assessed by creatinine levels |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by creatinine levels |
1week |
|
| Primary |
Treatment-emergent adverse effects as assessed by creatinine levels |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by creatinine levels |
6weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by creatinine levels |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by creatinine levels |
3months |
|
| Primary |
Treatment-emergent adverse effects as assessed by creatinine levels |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by creatinine levels |
6months |
|
| Primary |
Treatment-emergent adverse effects as assessed by creatinine levels |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by creatinine levels |
1year |
|
| Primary |
Treatment-emergent adverse effects as assessed by liver function tests |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by liver function tests |
1week |
|
| Primary |
Treatment-emergent adverse effects as assessed by liver function tests |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by liver function tests |
6weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by liver function tests |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by liver function tests |
3months |
|
| Primary |
Treatment-emergent adverse effects as assessed by liver function tests |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by liver function tests |
6months |
|
| Primary |
Treatment-emergent adverse effects as assessed by liver function tests |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by liver function tests |
1year |
|
| Primary |
Treatment-emergent adverse effects as assessed by complete blood count |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by complete blood count |
1week |
|
| Primary |
Treatment-emergent adverse effects as assessed by complete blood count |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by complete blood count |
6weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by complete blood count |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by complete blood count |
3months |
|
| Primary |
Treatment-emergent adverse effects as assessed by complete blood count |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by complete blood count |
6months |
|
| Primary |
Treatment-emergent adverse effects as assessed by complete blood count |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by complete blood count |
1year |
|
| Primary |
Treatment-emergent adverse effects as assessed by C-reactive protein |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by C-reactive protein |
1week |
|
| Primary |
Treatment-emergent adverse effects as assessed by C-reactive protein |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by C-reactive protein |
6weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by C-reactive protein |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by C-reactive protein |
3months |
|
| Primary |
Treatment-emergent adverse effects as assessed by C-reactive protein |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by C-reactive protein |
6months |
|
| Primary |
Treatment-emergent adverse effects as assessed by C-reactive protein |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by C-reactive protein |
1year |
|
| Primary |
Treatment-emergent adverse effects as assessed by erythrocyte sedimentation rate |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by erythrocyte sedimentation rate |
1week |
|
| Primary |
Treatment-emergent adverse effects as assessed by erythrocyte sedimentation rate |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by erythrocyte sedimentation rate |
6weeks |
|
| Primary |
Treatment-emergent adverse effects as assessed by erythrocyte sedimentation rate |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by erythrocyte sedimentation rate |
3months |
|
| Primary |
Treatment-emergent adverse effects as assessed by erythrocyte sedimentation rate |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by erythrocyte sedimentation rate |
6months |
|
| Primary |
Treatment-emergent adverse effects as assessed by erythrocyte sedimentation rate |
To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by erythrocyte sedimentation rate |
1year |
|
| 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 Umbilical cord-derived Wharton's Jelly as assessed by T, B and NK cell lymphocyte subsets |
1week |
|
| 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 Umbilical cord-derived Wharton's Jelly as assessed by T, B and NK cell lymphocyte subsets |
6weeks |
|
| 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 Umbilical cord-derived Wharton's Jelly as assessed by T, B and NK cell lymphocyte subsets |
3months |
|
| 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 Umbilical cord-derived Wharton's Jelly as assessed by T, B and NK cell lymphocyte subsets |
6months |
|
| 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 Umbilical cord-derived Wharton's Jelly as assessed by T, B and NK cell lymphocyte subsets |
1year |
|
| 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 Umbilical cord-derived Wharton's Jelly as assessed by serum IgG, IgA, IgM and IgE levels |
1week |
|
| 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 Umbilical cord-derived Wharton's Jelly as assessed by serum IgG, IgA, IgM and IgE levels |
6weeks |
|
| 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 Umbilical cord-derived Wharton's Jelly as assessed by serum IgG, IgA, IgM and IgE levels |
3months |
|
| 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 Umbilical cord-derived Wharton's Jelly as assessed by serum IgG, IgA, IgM and IgE levels |
6months |
|
| 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 Umbilical cord-derived Wharton's Jelly as assessed by serum IgG, IgA, IgM and IgE levels |
1year |
|
| 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 24hours 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 48hours 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 1week 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 6weeks 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 3months 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 6months 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 1year after injection |
|
| Secondary |
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score |
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score (KOOS). An increase in score indicates improvement. |
Change from baseline to 1week after injection |
|
| Secondary |
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score |
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score (KOOS). An increase in score indicates improvement. |
Change from baseline to 6weeks after injection |
|
| Secondary |
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score |
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score (KOOS). An increase in score indicates improvement. |
Change from baseline to 3months after injection |
|
| Secondary |
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score |
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score (KOOS). An increase in score indicates improvement. |
Change from baseline to 6months after injection |
|
| Secondary |
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score |
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score (KOOS). An increase in score indicates improvement. |
Change from baseline to 1year 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 1year after injection |
|
| Secondary |
Patient Satisfaction via 36-item short form survey (SF36) |
To determine patient satisfaction via 36-item short form survey (SF36) |
Change from baseline to 3Months after injection |
|
| Secondary |
Patient Satisfaction via 36-item short form survey (SF36) |
To determine patient satisfaction via 36-item short form survey (SF36) |
Change from baseline to 6Months after injection |
|
| Secondary |
Patient Satisfaction via 36-item short form survey (SF36) |
To determine patient satisfaction via 36-item short form survey (SF36) |
Change from baseline to 1year after injection |
|
| Secondary |
Patient Satisfaction via 7-point Likert Scale |
To determine patient satisfaction via 7-point Likert Scale. An increase in score indicates improvement. |
1week after injection |
|
| Secondary |
Patient Satisfaction via 7-point Likert Scale |
To determine patient satisfaction via 7-point Likert Scale. An increase in score indicates improvement. |
6weeks after injection |
|
| Secondary |
Patient Satisfaction via 7-point Likert Scale |
To determine patient satisfaction via 7-point Likert Scale. An increase in score indicates improvement. |
3months after injection |
|
| Secondary |
Patient Satisfaction via 7-point Likert Scale |
To determine patient satisfaction via 7-point Likert Scale. An increase in score indicates improvement. |
6months after injection |
|
| Secondary |
Patient Satisfaction via 7-point Likert Scale |
To determine patient satisfaction via 7-point Likert Scale. An increase in score indicates improvement. |
1year 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 1week 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 6weeks 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 3months 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 6months 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 1year after injection |
|
