Table 1.
Study identifier | Tissue/cell type | Study phase; estimated enrolment (n) | Primary outcome measure(s) | Recruitment status | Country |
---|---|---|---|---|---|
NCT04719793 | UD-WJ | Early phase I; n = 12 | 1) Treatment-emergent adverse effects as assessed by comprehensive metabolic profile; creatinine levels; liver function test; complete blood count; C-reactive protein; erythrocyte sedimentation rate; T, B and NK cell lymphocyte subset; serum IgG, IgA, IgM and IgE levels (time frame: 1 week, 6 weeks, 3 months, 6 months, 12 months): To determine safety, i.e. adverse events associated with IA administration of CCM as assessed by comprehensive metabolic profile; creatinine levels; liver function test; complete blood count; C-reactive protein; erythrocyte sedimentation rate; T, B and NK cell lymphocyte subset; serum IgG, IgA, IgM and IgE levels. | Not yet recruiting | USA |
NCT04711304 | UD-WJ | Phase I/II; n = 168 | 1) Adverse or severe adverse events associated with IA administration of UD-WJ (time frame: immediately after injection, 24 hours, 48 hours, 1 week, 6 weeks, 3 months, 6 months, 1 year): To determine safety, i.e. adverse or severe adverse events associated with IA administration of UD-WJ injection. Any adverse or severe adverse events will be recorded in the associated case report forms. 2) Patient Satisfaction associated with IA administration of UD-WJ (time frame: 1 week, 6 weeks, 3 months, 6 months, 1 year after injection): To determine patient satisfaction via 7-point Likert scale. An increase in score indicates improvement. 3) Patient Satisfaction associated with IA administration of UD-WJ (time frame: change from baseline to 3 months after injection, change from baseline to 6 months after injection, change from baseline to 1 year after injection): To determine patient satisfaction via a 36-item short form survey (SF36). |
Not yet recruiting | USA |
NCT03866330 | WJMSCs | Phase I/II; n = 100 | *Only knee-specific outcomes listed. 1) Change in KOOS score. [time frame: baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]. 2) Change in IKDC Questionnaire score. [time frame: baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]. 3) Change in WOMAC score. [time frame: baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]. 4) Change in Visual Analogue Scale (VAS) for pain in the target hip following completion of treatment cycles. [time frame: baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]. |
Unknown | Poland |
NCT02963727 | WJMSCs | Phase I; n = 10 | Evaluation of the safety and tolerability of the IA injection. Patients will be monitored for any adverse events resulting from the IA injection of WJMSC. (time frame: 6 months). |
Unknown | Jordan |
NCT04313894 | WJMSCs | Phase II; n = 11 | 1) Changing in pain (time frame: before injection and 15 day—30 day—45 day—3 months—6 months—12 months after injection). 2) Changing in functional knee score using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: before injection and 15 days—30 days—45 days—3 months—6 months—12 months after injection). 3) Changing in quality of life. Short Form 36 (time frame: before injection and 15 days—30 days—45 days—3 months—6 months—12 months after injection). (time frame: before injection and 15 days—30 days—45 days—3 months—6 months—12 months after injection). 5) Chondral and subchondral changes. Magnetic resonance imaging T2 mapping (msn): (time frame: before injection and 15 days—30 days—45 days—3 months—6 months—12 months after injection). 6) Changes in leptin levels in synovial fluid (ELISA) (time frame: before injection and 15 days—30 day—45 days—3 months—6 months—12 months after injection). 7) Changing in adiponectin levels in synovial fluid (ELISA) (time frame: before injection and 15 days—30 days—45 days—3 months—6 months—12 months after injection). 8) Changes in tumour necrosing factor-α levels in synovial fluid (ELISA) (time frame: before injection and 15 days—30 days—45 days—3 months—6 months—12 months after injection). 9) Changing in resistin levels in synovial fluid (ELISA) (time frame: before injection and 15 days—30 days—45 days—3 months—6 months—12 months after injection). 10) Changing in interleukin-6 levels in synovial fluid (time frame: before injection and 15 days—30 days—45 days—3 months—6 months—12 months after injection). 11) Changing in interleukin-1β levels in synovial fluid (ELISA) (time frame: before injection and 15 days—30 days—45 days—3 months—6 months—12 months after injection). |
Unknown | Turkey |
NCT04520945 | UC WJMSCs | Phase II; n = 100 | 1) VAS score. Change from baseline in VAS (time frame: 12 months). 2) WOMAC score. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index Score (WOMAC) (time frame: 12 months). 3) IKDC score. Change from baseline in knee function change and improvement (IKDC) (time frame: 12 months). 4) KOOS score. Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: 12 months). |
Unknown | Malaysia |
NCT04863183 | MSCs derived from WJ of UC | Phase I/II; n = 30 | 1) Decrease in joint pain. Pain will be measured through the VAS (time frame: 12 months). 2) Increased joint functionality. Joint functionality will be measured through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 12 months). 3) Improvement in the quality of life. Quality of life will be measured through the SF-36 (time frame: 12 months). 4) Imaging improvement of articular cartilage. The improvement of articular cartilage will be evaluated by magnetic resonance imaging (time frame: 12 months). |
Unknown | Colombia |