BC-101 in Treatment of Nasolabial Fold Wrinkles

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1/2 Study of the Safety and Efficacy of BC-101 in Treatment of Nasolabial Fold Wrinkles Via Subcutaneous/Intradermal Injection

Conditions
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Nasolabial Fold Wrinkles

Intervention / Treatment
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* Biological: BC-101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are in general good health condition. Subjects who have moderate to extremely deep bilateral nasolabial fold wrinkles, as documented by a score of 3 or greater on the six-point Evaluator Wrinkle Severity Assessment scale (0-5). Subjects who are dissatisfied with both nasolabial fold wrinkles based on a score of -1 or -2 on the Subject Wrinkle Assessment Scale (-2 to +2). Subjects who voluntarily adhere to the research procedures and ensure good compliance during the research period. Subjects who fully understand the research nature of this study and sign the informed consent. Exclusion Criteria: Subjects who have an active cutaneous infection on the face. Subjects with existing malignant neoplasm. Subjects with persistent pre-cancerous lesions (e.g., actinic keratosis). Subjects who have active dermal diseases, inflammation, or any related disease. Subjects who have cosmetic or surgical treatment on nasolabial fold area in 3 months before the study (including laser, chemical peels, fillers, botulinum toxin). Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study. Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BC-101<br>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. | Biological: BC-101<br>* Human umbilical cord tissue derived mesenchymal stem cells (hUC-MSC) suspension at concentration of 2, 4, or 6 million cells/mL.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of any treatment-emergent adverse events |  | 12 weeks after injection | 

Secondary Outcome Measures

| Outcome Measure | 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 |