Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
9 participants
INTERVENTIONAL
2026-12-01
2028-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
BC-101
Human umbilical cord tissue derived mesenchymal stem cells (hUC-MSC) suspension at concentration of 2, 4, or 6 million cells/mL.
Interventions
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BC-101
Human umbilical cord tissue derived mesenchymal stem cells (hUC-MSC) suspension at concentration of 2, 4, or 6 million cells/mL.
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
80 Years
ALL
No
Sponsors
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Bright Cell, Inc.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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BC101-C01
Identifier Type: -
Identifier Source: org_study_id