BC-101 in Treatment of Nasolabial Fold Wrinkles

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05162326

Enrollment

Registered

2021-12-17

Start date

2026-12-01

Completion date

2028-02-20

Last updated

2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasolabial Fold Wrinkles

Brief 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.

Interventions

BIOLOGICALBC-101

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

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Incidence of any treatment-emergent adverse events	12 weeks after injection

Secondary

Measure	Time frame	Description
Changes in wrinkle severity assessment from baseline	6 weeks, 12 weeks and 26 weeks after injection	Each of the bilateral nasolabial fold wrinkles at rest will be evaluated using the 6-point ordinal Lemperle Wrinkle Severity Scale.

Contacts

Primary ContactJennifer Wang

jenniferw@brightcellinc.com949-333-3636

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026