Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2024-12-11
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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low dose
TPX-115(allogeneic fibroblasts)
Intradermal injection of TPX-115(allogeneic fibroblasts)
middle dose
TPX-115(allogeneic fibroblasts)
Intradermal injection of TPX-115(allogeneic fibroblasts)
high dose
TPX-115(allogeneic fibroblasts)
Intradermal injection of TPX-115(allogeneic fibroblasts)
Interventions
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TPX-115(allogeneic fibroblasts)
Intradermal injection of TPX-115(allogeneic fibroblasts)
Eligibility Criteria
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Inclusion Criteria
2. Have confirmed nasolabial folds severity equal to or more than grade 3 evaluated by WSRS and WSS at face to face evaluation.
3. Have unsatisfied or very unsatisfied nasolabial folds.
4. Voluntarily sign the informed consent for participation in the study.
Exclusion Criteria
1. Inflammatory and infectious skin diseases, unhealed wounds and scars (e.g. Keloids), or benign tumor on nasolabial folds.
2. Chronic skin diseases (e.g. Psoriasis, Atopic dermatitis).
3. Genetic diseases that affect fibroblasts or collagen (e.g. Achondroplasia, Osteogenesis imperfecta).
4. Autoimmune diseases.
5. Active hepatitis B or C (However, in the case of simple carriers or hepatitis B, except when the antiviral agent was stably taken for 6 months prior to screening).
6. Human immunodeficiency virus (HIV) positive.
7. Coagulopathy.
8. History of malignant tumors within the last 5 years.
9. Anaphylaxis or severe combined allergy
10. Have allergies to bovine proteins or gentamicin.
11. Acute or chronic infectious diseases.
12. Severe heart diseases (e.g. Myocardial infarction, Heart failure), severe liver diseases (e.g. Cirrhosis, Liver failure), or severe renal diseases (e.g. Kidney failure).
13. Hypersensitivity to amide-based local anesthetics (However, those who agree not to use local anesthetics can register).
Prohibited drugs and treatments.
14. Administered systemic corticosteroids within 12 weeks prior to screening or is scheduled to be administered for at least 2 weeks during the study.
15. Treated cell therapy or stem cell therapy within 1 year prior to screening.
16. Surgical procedures or surgeries such as fillers or fat grafting on facial part within 1 year prior to screening.
17. Surgical procedures or surgeries of permanent fillers on facial part prior to screening.
18. Surgical procedures or surgeries of botulinum toxin injection or face lift surgery on facial part within 6 months prior to screening.
19. Planned facial cosmetic surgery to improve nasolabial folds during the study.
Laboratory inspection
20. Those who fall under the following figures during screening. 1) White blood cell \< 4.5x10\^3/ul and \> 11.0x10\^3/ul 2) Platelet count \< 100,000/mm\^3 3) Hemoglobin \< 9g/dL
Other
21. Disagree to take pictures of nasolabial folds
22. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptice.
23. Have participated in other clinical trials and recevied investigational products/devices within 30 days of this study.
24. Be deemed inadequate for the study by investigators(e.g. A person with severe asymmetry in the lower echocardiogram).
19 Years
ALL
No
Sponsors
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Tego Science, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Hoyun Chung, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kyungpook National University, School of Medicine
Locations
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Kyungpook National University, School of Medicine
Daegu, Jung-gu, South Korea
Countries
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Other Identifiers
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TG-TPX-121-23-01
Identifier Type: -
Identifier Source: org_study_id
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