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To evaluate repigmentation and quality of life after treatment of stable vitiligo lesions using the RECELL Device.
Prospective, multicenter single-arm pre-/post interventional study to evaluate the clinical performance of RECELL for repigmentation of stable depigmented lesions.Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy.
Repigmentation of treatment areas will be determined via centralized image interpretation by an expert dermatological panel (i.e., Central Review Committee, CRC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Treatment | Other | Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RECELL® Autologous Cell Harvesting Device | Device | The RECELL Device is for use at the patient's point-of-care for the safe and rapid preparation of Spray-On SkinTM Cells from a small sample of a patient's own skin. |
| Measure | Description | Time Frame |
|---|---|---|
| Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%) | Central Review Committee categorization of index area repigmentation | 24 weeks post-treatment |
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Inclusion Criteria:
Focal, segmental, or generalized (i.e., nonsegmental) stable vitiligo, defined as no new depigmented areas nor any depigmented areas that have expanded in size within the preceding 12 months.
The patient is a candidate for surgical intervention of a depigmented area, defined as a patient who has not satisfactorily responded to either:
The patient has a depigmented area available for treatment that is:
The patient is 18 years of age or older.
The patient agrees to remain on any current use of immunosuppressive therapy for the duration of his/her participation in the study (52 weeks).
The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up study visits.
The patient agrees to abstain from any other treatment of the study area for the duration of his/her participation in the study (52 weeks).
The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation in the study (52 weeks).
In the opinion of the investigator, the patient must be able to:
Exclusion Criteria:
The patient is unable to undergo treatment area preparation.
Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 or CTP009.
Patients with:
Patients with recent history (within previous 12 months) of:
Patients with a history of keloid formation.
The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
Current use of medications (e.g., anticoagulants such as heparin or warfarin) that in the investigator's opinion may compromise patient safety or trial objectives.
The patient has a known hypersensitivity to trypsin, compound sodium lactate for irrigation solution (Hartmann's solution), povidone-iodine, chlorhexidine, and/or lidocaine-containing anesthetics -
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Dermatology | Scottsdale | Arizona | 85225 | United States | ||
| University of California, Irvine |
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|
| Irvine |
| California |
| 92697 |
| United States |
| West Dermatology Research Center | San Diego | California | 92121 | United States |
| Sutter Health | Sunnyvale | California | 94086 | United States |
| California Dermatology Institute | Thousand Oaks | California | 91320 | United States |
| Clarity Dermatology | Castle Rock | Colorado | 80109 | United States |
| Siperstein Dermatology Group | Boynton Beach | Florida | 33437 | United States |
| Skin Care Research, LLC | Hollywood | Florida | 33021 | United States |
| Dermatologic Surgery Center of Washington | Chevy Chase | Maryland | 20815 | United States |
| Maryland Laser, Skin & Vein Institute | Hunt Valley | Maryland | 21030 | United States |
| University Of Massachusetts | Worcester | Massachusetts | 01605 | United States |
| Hamzavi Dermatology | Canton | Michigan | 48187 | United States |
| Henry Ford Health | Detroit | Michigan | 48202 | United States |
| Grekin Skin Institute | Warren | Michigan | 48088 | United States |
| The Dermatology Specialist | New York | New York | 10012 | United States |
| Mount Sinai | New York | New York | 10028 | United States |
| Dermatology, Laser and Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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