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NCT Number: NCT05162326

BC-101 in Treatment of Nasolabial Fold Wrinkles

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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Key information

Conditions

Nasolabial Fold Wrinkles

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BC-101

Biological

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

Primary outcomes

  1. Incidence of any treatment-emergent adverse events

    Time frame: 12 weeks after injection

Secondary outcomes

  1. Changes in wrinkle severity assessment from baseline

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Wang

CONTACT

[email protected]

949-333-3636

Sponsors and collaborators

Lead sponsor

Bright Cell, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 17, 2021
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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