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This is an open-label, single-arm, dose-escalating study to evaluate the safety and tolerability of BC-101 administered via subcutaneous/intradermal injection in the treatment of moderate to severe nasolabial folds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BC-101 | Experimental | BC-101 will be injected at the dose of 0.1 mL per linear centimeter along the nasolabial fold, up to 2 mL in total volume for each side of the nasolabial folds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BC-101 | Biological | Human umbilical cord tissue derived mesenchymal stem cells (hUC-MSC) suspension at concentration of 2, 4, or 6 million cells/mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of any treatment-emergent adverse events | 12 weeks after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in wrinkle severity assessment from baseline | Each of the bilateral nasolabial fold wrinkles at rest will be evaluated using the 6-point ordinal Lemperle Wrinkle Severity Scale. | 6 weeks, 12 weeks and 26 weeks after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Wang | Contact | 949-333-3636 | jenniferw@brightcellinc.com |
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