BC-101 in Treatment of Nasolabial Fold Wrinkles

Nasolabial Fold Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05162326
• Other study ID #: BC101-C01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 1, 2023
• Est. completion date: February 20, 2025

Study information

• Verified date: September 2023
• Source: Bright Cell, Inc.
• Contact: Jennifer Wang
• Phone: 949-333-3636
• Email: jenniferw[@]brightcellinc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: February 20, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subjects who are in general good health condition.

2. 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).

3. 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).

4. Subjects who voluntarily adhere to the research procedures and ensure good compliance during the research period.

5. Subjects who fully understand the research nature of this study and sign the informed consent.

Exclusion Criteria:

1. Subjects who have an active cutaneous infection on the face.

2. Subjects with existing malignant neoplasm.

3. Subjects with persistent pre-cancerous lesions (e.g., actinic keratosis).

4. Subjects who have active dermal diseases, inflammation, or any related disease.

5. Subjects who have cosmetic or surgical treatment on nasolabial fold area in 3 months before the study (including laser, chemical peels, fillers, botulinum toxin).

6. Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study.

7. Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.

Related Conditions & MeSH terms

• Nasolabial Fold Wrinkles

Intervention

Biological:
• BC-101
Human umbilical cord tissue derived mesenchymal stem cells (hUC-MSC) suspension at concentration of 2, 4, or 6 million cells/mL.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bright Cell, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of any treatment-emergent adverse events		12 weeks after injection
Secondary	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