BC-101 in Treatment of Nasolabial Fold Wrinkles

September 6, 2023 updated by: Bright Cell, Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of any treatment-emergent adverse events
Time Frame: 12 weeks after injection
12 weeks after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks, 12 weeks and 26 weeks after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bright Cell, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

February 20, 2025

Study Registration Dates

First Submitted

December 4, 2021

First Submitted That Met QC Criteria

December 4, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • BC101-C01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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