Atrophic ScarPhase 1/2NCT07474467
Safety and Efficacy of Autologous Adipose-derived Mesenchymal Stem Cells Therapy in Adults With Atrophic Scars
A Phase 1/2 study testing TRTP-101 in people with Atrophic Scar, run by CellinCells at 1 site in South Korea.
Trial summary
The purpose of this clinical trial was to evaluate the safety and efficacy of a single administration of TRTP-101 in adults with atrophic scars. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrophic Scar
- What is being tested?
- TRTP-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2026to 1 Aug 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female aged greater than 19 years
- Acne scars graded ≥ 3 on the 5-point ASRS
- [Phase 1]
- Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose
- [Phase 2]
- Atrophic scar lesions approximately 2 cm in diameter located on the cheeks or temple on both sides of the face
- A response of "dissatisfied" or worse on the Subject Acne Scar Self-Assessment Scale
Who cannot join
- History of cell therapy
- Treatment of Dermal resurfacing, Chemical/Mechanical Peel and Skin Photorejuvenation
- Treatment of Hyaluronic acid/collagen skin filler, non-permanent soft tissue filler and fat grafting
- Positive for virus infection
- Use of Anticoagulant therapy or NSAIDs
- Thrombocytopenia or other coagulation disorder
Show all 12Show fewer
- History of keloid scars
- Infectious disease or other dermatitis in the area of the atrophic scar
- Use of Immunosuppressant, immunomodulating drug, anticancer drug or radiation therapy
- Use of systemic steroid medication
- History of hypersensitivity or severe allergic reactions (e.g., anaphylaxis, Guillain-Barre syndrome, etc.)
- Use of retinoid medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Split-Face, Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Administration of TRTP-101 in Adults With Atrophic Scars
The purpose of this clinical trial was to evaluate the safety and efficacy of a single administration of TRTP-101 in adults with atrophic scars.
Read the detailed description
A phase 1 clinical trial designed to evaluate dose-limiting toxicity (DLT) following single-dose administration of TRTP-101 into four or more atrophic scar sites.
Subsequently, a phase 2 clinical trial will be conducted using a placebo-controlled, split-face design to evaluate the safety and efficacy of TRTP-101. Eligible subjects will have atrophic scars approximately 2 cm in diameter located on both sides of the face (e.g., the cheek or temple areas), and TRTP-101 and placebo will be administered to the respective sides of the face.
- Conditions
- Atrophic Scar
- Being tested
- TRTP-101, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRTP-101Biological
Intradermal injection
PlaceboBiological
Intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| TRTP-101 | Experimental | High-dose TRTP-101 Receives: Biological: TRTP-101 |
| TRPT-101 (Low dose group) | Experimental | In a split-face design, low-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side. Receives: Biological: TRTP-101 |
| Placebo (Low dose group) | Placebo comparator | In a split-face design, placebo is administered to one side of the face and low-dose TRTP-101 to the contralateral side. Receives: Biological: Placebo |
| TRPT-101 (High dose group) | Experimental | In a split-face design, high-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side. Receives: Biological: TRTP-101 |
| Placebo (High dose group) | Placebo comparator | In a split-face design, placebo is administered to one side of the face and high-dose TRTP-101 to the contralateral side. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Phase 1] Number of Subjects with Dose Limiting Toxicity
Dose Limiting Toxicity is defined as Grade ≥ 3 adverse drug reaction according to CTCAE criteria for 4 weeks after administration of TRTP-101
Measured: within 4 weeks
[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement from baseline in ASRS
Proportion of subjects with ≥ 1-grade improvement from baseline in ASRS (Acne Scar Rating Scale) at 12, 24 weeks after treatment, as assessed by independent reviewers using a standardized photoguide
*The Acne Scar Rating Scale (ASRS) is a 5-grade scale ranging from 0 to 4 (0 = Clear, 1 = Very mild, 2 = Mild, 3 = Moderate, and 4 = Severe). Higher grades indicate greater severity of atrophic scars and therefore a worse outcome.
Measured: 12, 24 weeks after treatment
Secondary outcomes (2)
[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement on the GAIS
Proportion of subjects with ≥ 1-point improvement from baseline on the GAIS (Global Aesthetic Improvement Scale) at 12, 24 weeks after treatment, as assessed by independent reviewers.
*The Global Aesthetic Improvement Scale (GAIS) is a 5-grade scale ranging from -1 to 3 (-1 = Worse, 0 = No change, 1 = Improved, 2 = Much improved, and 3 = Very much improved). Higher grades indicate greater aesthetic improvement and therefore a better outcome.
Measured: 12, 24 weeks after treatment
[Phase 2] Distribution of subjects by treatment satisfaction score
Distribution of subjects by treatment satisfaction score at 12, 24 weeks after treatment, assessed using the Subject Acne Scar Self-Assessment Scale.
*The Subject Acne Scar Self-Assessment Scale is a 5-grade scale ranging from -2 to +2 (-2 = Very dissatisfied, -1 = Dissatisfied, 0 = Somewhat satisfied, +1 = Satisfied, and +2 = Very satisfied). Higher grades indicate greater satisfaction with acne scars and therefore a better outcome.
Measured: 12, 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start12 Aug 2026
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CellinCells
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonghee Lee, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474467
- Sponsor's protocol ID
- CIC101-02
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Split-Face, Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Administration of TRTP-101 in Adults With Atrophic Scars
- ClinicalTrials.gov ID
- NCT07474467
- Acronym / sponsor ID
- CIC101-02
- Conditions
- Atrophic Scar
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- CellinCellsIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial was to evaluate the safety and efficacy of a single administration of TRTP-101 in adults with atrophic scars.
Detailed description
A phase 1 clinical trial designed to evaluate dose-limiting toxicity (DLT) following single-dose administration of TRTP-101 into four or more atrophic scar sites.
Subsequently, a phase 2 clinical trial will be conducted using a placebo-controlled, split-face design to evaluate the safety and efficacy of TRTP-101. Eligible subjects will have atrophic scars approximately 2 cm in diameter located on both sides of the face (e.g., the cheek or temple areas), and TRTP-101 and placebo will be administered to the respective sides of the face.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TRTP-101 | Experimental | Biological: TRTP-101High-dose TRTP-101 |
| TRPT-101 (Low dose group) | Experimental | Biological: TRTP-101In a split-face design, low-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side. |
| Placebo (Low dose group) | Placebo comparator | Biological: PlaceboIn a split-face design, placebo is administered to one side of the face and low-dose TRTP-101 to the contralateral side. |
| TRPT-101 (High dose group) | Experimental | Biological: TRTP-101In a split-face design, high-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side. |
| Placebo (High dose group) | Placebo comparator | Biological: PlaceboIn a split-face design, placebo is administered to one side of the face and high-dose TRTP-101 to the contralateral side. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female aged greater than 19 years
- Acne scars graded ≥ 3 on the 5-point ASRS
- [Phase 1]
- Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose
- [Phase 2]
Key exclusion criteria (12 listed)
- History of cell therapy
- Treatment of Dermal resurfacing, Chemical/Mechanical Peel and Skin Photorejuvenation
- Treatment of Hyaluronic acid/collagen skin filler, non-permanent soft tissue filler and fat grafting
- Positive for virus infection
- Use of Anticoagulant therapy or NSAIDs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRTP-101Intradermal injection | Biological | TRPT-101 (High dose group), TRPT-101 (Low dose group), TRTP-101 |
| PlaceboIntradermal injection | Biological | Placebo (High dose group), Placebo (Low dose group) |
Primary outcome
[Phase 1] Number of Subjects 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
[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement from baseline in ASRS
Time frame: 12, 24 weeks after treatment
Proportion of subjects with ≥ 1-grade improvement from baseline in ASRS (Acne Scar Rating Scale) at 12, 24 weeks after treatment, as assessed by independent reviewers using a standardized photoguide *The Acne Scar Rating Scale (ASRS) is a 5-grade scale ranging from 0 to 4 (0 = Clear, 1 = Very mild, 2 = Mild, 3 = Moderate, and 4 = Severe). Higher grades indicate greater severity of atrophic scars and therefore a worse outcome.
2 secondary outcomes
[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement on the GAIS
Time frame: 12, 24 weeks after treatment
[Phase 2] Distribution of subjects by treatment satisfaction score
Time frame: 12, 24 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Atrophic Scar
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Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonghee Lee, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TRTP-101 in people with Atrophic Scar, run by CellinCells at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HyeJung Park (+82-70-4469-9115, hjpark@cellincells.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Phase 1] Number of Subjects with Dose Limiting Toxicity (time frame: within 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.