Health TrialsbyHealthPanel

BC-101 in Treatment of Nasolabial Fold Wrinkles

ConditionNasolabial Fold Wrinkles
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorBright Cell, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BC-101

    Biological/Vaccine

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

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: BC-101Experimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bright Cell, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: