Patients with post-traumatic chronic wrist pain, with imaging and previous arthroscopic evidence of wrist carpal bone chondral defects who opt for active treatment
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Wrist pain of mechanical origin(post-traumatic); 2. The pain cannot be relieved by treating other underlying defects other than carpal affections; 3. Patients with imaging and previous arthroscopic evidence of wrist carpal bone chondral defects; 4. Absence of any local or general infection; 5. Hematologic and biochemical analyses with no significant alterations that contraindicate intervention; 6. Patient who is able to understand the nature the study and provide informed written consent.
Exclusion criteria
Exclusion criteria: 1. Age older than 75 or younger than 18 years old or legally dependent; 2. Patients with past history of hematologic disorders; 3. Signs of infection or positive serology for HIV, HBV, HCV, or syphilis; 4. Congenital or acquired diseases leading to significant wrist deformities that may interfere with cell application or interpretation of results; 5. Pregnancy or breast, feeding, Neoplasia, Immunosuppression, Participation in another clinical trial or treatment with another investigational product within 30 days before inclusion in the study; 6. Patients with alcoholism/drug abuse; 7. Other medical conditions that may discourage participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic radiological (MRI)assessments will be done at post-injection 6th month.; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS, functional wrist score, PRWE, DASH, Power, ROM at post-injection 3rd, 6th, 12nd and 24th month; | — |
Countries
China