BC-101 in Treatment of Nasolabial Fold Wrinkles

NCT05162326 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BC101-C01
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasolabial Fold Wrinkles

Outcome Measures

Primary Outcomes (1)

• Incidence of any treatment-emergent adverse events

  12 weeks after injection

Secondary Outcomes (1)

• Changes in wrinkle severity assessment from baseline

  6 weeks, 12 weeks and 26 weeks after injection

Study Arms (1)

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.

Biological: BC-101

Interventions

BC-101 BIOLOGICAL

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

BC-101

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bright Cell, Inc.: lead

Central Study Contacts

Jennifer Wang

CONTACT

949-333-3636; jenniferw@brightcellinc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: December 17, 2021
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): February 20, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12