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Evaluate the injections of Ji Gami(TM) and Ji Gami(TM) DO, where cells are expanded ex vivo from scalp, to induce hair growth in male and female subjects with hair loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous cultured dermal and epidermal cells | Biological | A piece of occipital scalp, plucked of hairs prior to excision, is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. The cells are then injected into the balding area of the scalp of the original subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in hair number | 51 weeks post-injection | |
| Change from baseline in hair width | 51 weeks post-injection | |
| Time course of any treatment benefit | 51 weeks post-injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axis Clinical Trials | Los Angeles | California | 90036 | United States | ||
| Impact Clinical Trials |
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|
| Las Vegas |
| Nevada |
| 89106 |
| United States |
| Axis Clinical Trials | New Hyde Park | New York | 11042 | United States |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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