LAVIV is an autologous cellular product composed of fibroblasts suspended in Dulbecco’s Modified Eagle’s Medium (DMEM) without phenol red. Dermal fibroblasts from post-auricular skin biopsy tissue are aseptically expanded using standard tissue-culture procedures until sufficient cells for three doses are obtained.
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PARAMETER |
DATA |
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Manufacturer |
Fibrocell Technologies, Inc. |
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Transgene |
- |
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Indication |
LAVIV® (azficel-T) is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. |
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Virus & Serotype |
- |
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Cell Substrate |
Autologous fibroblasts |
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Manufacturing platform |
It is a cellular product composed of fibroblasts suspended in Dulbecco’s Modified Eagle’s Medium (DMEM) without phenol red. Dermal fibroblasts from post-auricular skin biopsy tissue are aseptically expanded using standard tissue-culture procedures until sufficient cells for three doses are obtained. Cells are then cryopreserved in a protein-free solution containing DMSO. |
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Dose in vial/final container |
18 million autologous fibroblasts in a 1.2 milliliters suspension, sufficient to administer 1 milliliter of product. |
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Dose / patient |
0.1 milliliter per linear centimeter into the nasolabial fold wrinkles. The recommended treatment regimen is three treatment sessions at 3-6 week intervals. |
CLINICAL STUDIES:
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NCT |
TRIAL PHASE |
SUBJECTS ENROLLED |
STUDY TITLE |
COUNTRIES |
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NCT00649428 |
3 |
203 |
Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles |
United States |
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NCT00655356 |
3 |
218 |
Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles |
United States |
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NCT00654654 |
2 |
50 |
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases |
United States |
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NCT00642642 |
2, 3 |
122 |
Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring |
United States |
| 06/21/2011 | FDA approval date |
An FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting took place on 9th October 2009, in Bethesda, Maryland. Topics covered at the AC meeting included tumorigenicity potential of the fibroblast cell suspension; potential risk for hypertrophic scarring, keloid formation, or abnormal pigmentation, in the non-White population; potential safety risks in patients over 65 years of age and in males; and a post-marketing training program for practitioners.