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. 2023 Dec 7;149(1):13–31. doi: 10.1093/bmb/ldad030

Table 1.

Clinical trials registered on ClinicalTrials.gov till November 10, 2023, using WJ for the management of knee OA

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