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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CartiLage Auto/Allo IMplantation for Focal Hip Cartilage Defects | Experimental | Subject will receive the combined product of autologous cartilage cells and allogeneic AMSCs in a fibrin glue carrier. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Chondrocytes in their Pericellular Matrix (Chondrons) Coimplanted with Allogeneic Adipose-Derived Mesenchymal Stromal Cells (AMSCs) in a Fibrin Glue Carrier | Combination Product | Cartilage cells are being used from the rim of the defect in the hip and recycled to help make new cartilage in the hip. There are not enough cartilage cells to fill the defect so cartilage cells need to be mixed with MSCs. MSCs or Mesenchymal Stem Cells are naturally occurring cells that provide growth factors and cell signals that play a role in tissue repair. MSCs can be found in bone marrow and in the fatty tissues (i.e., area under the skin of the belly or breast) of patients. Fibrin glue is a product made from the naturally occurring compounds in blood which cause clotting. This glue hardens into a gel-like substance into which cells such as cartilage cells (chondrons) and AMSCs can be placed. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Number of adverse events defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship. | 2 years |
| Incidence of serious adverse events (SAEs) | Number of SAEs as defined as AEs that result in death, life threatening adverse experiences, hospitalization, new or prolonged disability/incapacity, persistent or significant congenital defect/anomaly, or other events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain | Measured using self-reported 10 mm VAS | Baseline, 1-2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 18 months, and 24 months post-treatment |
| Change in physical function | Measured using the PROMIS-CAT-Physical Function assessment with questions to evaluate self-reported physical function on a scale of 5 to 1, with higher scores indicating better outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Krych, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
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| Baseline, 1-2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 18 months, and 24 months post-treatment |
| Change in hip function | Measured using the International Hip Outcome Tool (IHOT12). 12-item self-reported questionnaire assessing function of hip on a scale of 0 to 10, with higher outcomes indicating worse outcomes | Baseline, 1-2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 18 months, and 24 months post-treatment |