BC-101 in Treatment of Nasolabial Fold Wrinkles
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BC-101.
- Who it may be relevant to
- Registry conditions: Nasolabial Fold Wrinkles. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1/2 Study of the Safety and Efficacy of BC-101 in Treatment of Nasolabial Fold Wrinkles Via Subcutaneous/Intradermal Injection
Overview
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
- Biological BC-101
Human umbilical cord tissue derived mesenchymal stem cells (hUC-MSC) suspension at concentration of 2, 4, or 6 million cells/mL.
Primary outcome measures
- Incidence of any treatment-emergent adverse events [Time frame: 12 weeks after injection]
Secondary outcome measures (1)
- Changes in wrinkle severity assessment from baseline [Time frame: 6 weeks, 12 weeks and 26 weeks after injection]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05162326 · BC101-C01