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Per updated regulatory requirements, the site is ineligible to proceed. The clinical institution office has terminated the project.
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Many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. There are devastating physical and psychological consequences as a result. Exosomes are isolated from donated human mesenchymal stem cells and purified using specific processing. This study is a randomized, double-blind, dose-escalation clinical trial designed to evaluate the efficacy and safety of exosomes therapy for alopecia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exosomes | Experimental | Subjects will receive 5E8 ~5E9 particles/cm² of exosome therapy in the study area during the dose escalation phase. |
|
| saline | Placebo Comparator | The control site will receive the same volume of saline as the exosomes administered in the study site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exosomes | Biological | Each subject will receive 3 injections with an interval of one month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of localized hair density | Quantify hair counts within designated 1.5 cm × 1.5 cm fixed areas in both the study area and control area, and compare the localized hair density (hair/cm²) between the two areas. | 3rd month after 3 treatments |
| Safety Assessment | Incidence of treatment emergent adverse events (TEAEs) | From the initial treatment administration to the subject withdrawal from the study. |
| Comparison of overall hair density | Evaluate and score overall hair density in both the study area and control area using an 8-level assessment scale, followed by a comparative analysis of the two areas. | 3rd month after 3 treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Change of hair density | Change in hair density of study area with the baseline. | 3rd and 6st month after 3 treatments |
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Inclusion Criteria:
1) BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or special type (V1 to V3, or F1 to F3); 2) For female: Ludwig Grade I to II. Or for male: Hamilton-Norwood Grade III to IV; 3) Hair density by phototrichogram: ≤ 190 hair/cm² ; 4. Hair dryness ≥ 5%; 5. Until withdrawal/completion of the study, subjects agree not to undergo any topical treatment for hair loss and agree to use a neutral shampoo.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Qianhai Shekou Free Trade Zone Hospital | Shenzhen | Guangdong | 518067 | China |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| saline | Other | Each subject will receive 3 injections with an interval of one month. |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |