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Not yet recruitingNCT05162326Updated Dec 29, 2025

BC-101 in Treatment of Nasolabial Fold Wrinkles

A Phase 1 interventional study of BC-101 in Nasolabial Fold Wrinkles, sponsored by Bright Cell, Inc.. Not yet recruiting. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by Bright Cell, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nasolabial Fold Wrinkles
03

In context

Lead sponsor

Bright Cell, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Experimental
    BC-101

    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

  • BiologicalBC-101

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

06

What researchers measure

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

    Each of the bilateral nasolabial fold wrinkles at rest will be evaluated using the 6-point ordinal Lemperle Wrinkle Severity Scale.

    Time frame: 6 weeks, 12 weeks and 26 weeks after injection

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05162326
Lead sponsor
Bright Cell, Inc.
Responsible party
Sponsor
First posted
Dec 17, 2021
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 30, 2027 (estimated)
Completion
Feb 20, 2028 (estimated)
Last update
Dec 29, 2025

Study contacts

Jennifer Wang
Contact
jenniferw@brightcellinc.com
949-333-3636

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Bright Cell, Inc.

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