Safety and Tolerability of Autologous Adipose-derived Mesenchymal Stem Cells Therapy in Adults With Atrophic Scars

January 8, 2024 updated by: CellinCells

A Phase 1, Single-Center, Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Single Dose of TRTP-101 in Adults With Atrophic Scars

The purpose of this clinical trial was to evaluate the safety and tolerability for 12 weeks after one dose of TRTP-101 in adults with atrophic scars.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A phase 1 clinical trial to evaluate dose-limiting toxicity by administering a singe dose of TRTP-101 to each of the four sites of atrophic scar.

Study Type

Interventional

Enrollment (Estimated)

3

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

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or Female aged greater than 19 years
  2. Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose

Exclusion Criteria:

  1. History of cell therapy
  2. Treatment of Dermal resurfacing, Chemical/Mechanical Peel and Skin Photorejuvenation
  3. Treatment of Hyaluronic acid/collagen skin filler, non-permanent soft tissue filler and fat grafting
  4. Positive for virus infection
  5. Use of Anticoagulant therapy or NSAIDs
  6. Thrombocytopenia or other coagulation disorder
  7. History of keloid scars
  8. Infectious disease or other dermatitis in the area of the atrophic scar
  9. Use of Immunosuppressant, immunomodulating drug, anticancer drug or radiation therapy
  10. Use of systemic steroid medication
  11. History of hypersensitivity or severe allergic reactions (e.g., anaphylaxis, Guillain-Barre syndrome, etc.)
  12. Use of retinoid medications

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRTP-101
Micro-Block (MiB) manufactured from autologous Adipose-derived Mesenchymal Stem Cells
Biological: TRTP-101
Intradermal injection of the each of four sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Dose Limiting Toxicity
Time Frame: within 4 weeks
Dose Limiting Toxicity is defined as Grade ≥ 3 adverse drug reaction according to CTCAE criteria for 4 weeks after administration of TRTP-101
within 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean percent change in atrophic scar volume
Time Frame: 1, 4, 8 and 12 weeks
The depressed volume of atropic scar is measured at baseline and post-treatment visits
1, 4, 8 and 12 weeks

Collaborators and Investigators

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

Sponsor

CellinCells

Investigators

  • Principal Investigator: Jonghee Lee, MD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 6, 2023

Primary Completion (Estimated)

July 5, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Estimated)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIC101-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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Locations

3
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