A Study of REcycled CartiLage Auto/Allo IMplantation to Treat and Repair Focal Hip Cartilage Defects (NCT05553132) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of REcycled CartiLage Auto/Allo IMplantation to Treat and Repair Focal Hip Cartilage Defects
United States15 participantsStarted 2023-08-08
Plain-language summary
The purpose of this research study it to gather information on the safety and side effects of treating cartilage defects with autologous cartilage cells mixed with allogeneic adipose-derived mesenchymal stem cells (AMSCs) in a fibrin glue.
Who can participate
Age range18 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Persons of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) at the time of screening. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered, and the result will be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed by qualified personnel using kit. Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
* Chronic (\> 3 months), unilaterally symptomatic, ICRS Grade III or IV cartilage lesions ranging in size from 2 to 6 cm2. Patients with episodes of contralateral hip pain that is asymptomatic at the time of enrollment will be eligible for inclusion. However, patients with previous episodes of contralateral hip pain who experience a repeat episode of contralateral pain similar to their established pattern of pain during the course of the trial will not be considered as having experienced an adverse event.
* Radiographic…