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The clinical trial will be carried out at the Gatot Soebroto Army Central Hospital, Jakarta and planned from June 2020 to December 2020. Clinical trials of Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs) and Conditioned Medium Umbilical Cord-Mesenchymal Stem Cells (CM UC-MSCs) for Keloid were designed in three groups. Group 1 injected with The UC-MSCs at a dose of 2 million cells / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at a dose of 1 cc / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at the same dose 3 weeks later. Group 3 injected with Triamcinolon acetonide (TA) at a dose of 40 mg / cc / cm3 using 1 cc (27 G) syringe and booster with TA at 3 weeks later. The study subjects each group amounted to 7 patients suffering from Keloid. Patients were evaluated for 3 months after injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC-MSCs + CM | Experimental | A patient will be given UC-MSCs 2 million cells / cm3. After 3 weeks, the patient will be given CM 1 cc / cm3. The maximum size of Keloid is 15 cm per patient. |
|
| CM + CM | Experimental | A patient will be given CM 1 cc / cm3. After 3 weeks, the patient will be given CM 1 cc / cm3. The maximum size of Keloid is 15 cm per patient. |
|
| Triamcinolon acetonide | Experimental | A patient will be given Triamcinolone acetonide 40 mg / cc / cm3. After 3 weeks the patient will be given Triamcinolone acetonide 40 mg/cc / cm3. The maximum size of Keloid is 15 cm per patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium | Biological | Injection of Allogeneic Umbilical Cord Mesenchymal Stem Cells 2 million cell/cm3 in Nacl 1 cc/million cell and booster with Conditioned Medium 1 cc/cm3 in 3 weeks later. All treatment via intralesional injection. The maximum size of the keloid is 15 cm. |
| Measure | Description | Time Frame |
|---|---|---|
| Alfa SMA-1 | Biomarker | 3 month after injection |
| Collagen type 1 | Biomarker | 3 moth after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Core Biopsy/Histopathology | Too evaluate histology of keloid | 3 month after injection |
| Ultrasonography | To see image inside the body |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anastasia Dessy Harsono, Master | Contact | 087888363270 | anastasia.bedahplastik@gmail.com | |
| Cynthia Retna Sartika, Doctor | Contact | c.sartika@gmail.com |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
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| ID | Term |
|---|---|
| D017077 | Culture Media, Conditioned |
| D000089282 | Secretome |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D003470 | Culture Media |
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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|
| Conditioned Medium | Biological | Injection of Conditioned Medium 1 cc/cm3 and booster with Conditioned Medium 1 cc/cm3 in 3 weeks later. All treatment via intralesional injection. The maximum size of the keloid is 15 cm. |
|
|
| Triamcinolone Acetonide | Biological | Injection of Triamcinolone Acetonide 40 mg/cc/cm3 and booster in 3 weeks later. All treatment via intralesional injection. The maximum size of the keloid is 15 cm. |
|
| 3 month after injection |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004864 | Equipment and Supplies |
| D055442 | Metabolome |
| D008660 | Metabolism |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |