Autologous Fibroblast Transplantation in Facial Deformities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2015-11-30

Brief Summary

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Beautiful skin requires maintenance of proper care. Skin exercise, protections from direct sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good and radiant skin. However despite all the care taken passage of time will bring about conditions that will automatically lead to skin aging, which may require certain therapeutic, care. Fibroblasts are cells that synthesize the extracellular matrix and collagen and play a critical role in wound healing and maintenance of healthy skin. Loosing of fibroblast cell is the main problem in aging and wrinkles and non-healed skin wounds. Therefore proliferation of skin fibroblast along with differentiation of stem cells in the skin tissue is the best method for healing.

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Detailed Description

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Autologous cultured fibroblast is derived from in vitro expansion of fibroblasts harvested from the patient's normal skin. Biopsies from behind a patient's ear are the source of fibroblasts, which are isolated, expanded through cell culture, and used for the correction of facial contour deformities such as nasolabial folds, glabellar crease, deep wrinkles of the forehead, and acne scars. Prior to final packaging, cell viability is assessed to be at least 85%.

Each single use container of autologous cultured fibroblasts has approximately 20 million cells aseptically processed and suspended in 1 mL of sterile, buffered Dulbecco's Modified Eagles Medium (DMEM). Both the biopsy transport media and the cell culture media contain gentamicin. Residual quantities of gentamicin up to 5 µg/mL may be present in the Cell product

Conditions

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Nasolabial Folds Glabellar Crease Deep Wrinkles of the Forehead Acne Scars

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fibroblast

Injection of autologous cultured fibroblast

Group Type EXPERIMENTAL

Fibroblast

Intervention Type BIOLOGICAL

20 million cell in three injection

fibroblast and gel

Intervention Type BIOLOGICAL

20 million cell in three injection plus filler

Interventions

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Fibroblast

20 million cell in three injection

Intervention Type BIOLOGICAL

fibroblast and gel

20 million cell in three injection plus filler

Intervention Type BIOLOGICAL

Other Intervention Names

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cell alone

Eligibility Criteria

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Inclusion Criteria

* Available and willing to attend all follow-up visits.
* Age \> 18 years.
* Able and willing to give informed consent.

Exclusion Criteria

* Known allergy or sensitivity to collagen fillers
* The subject has received a soft tissue augmentation to the area to be treated within the last 6 months.
* Subject is unwilling to forgo any cosmetic augmentation procedures for the duration of the study.
* The subject has received autologous fat transfer in the last 6 months.
* Subject is suffering from facial Kaposi's sarcoma.
* The subject has active skin diseases or inflammation on or near the area of injection
* positive HIV, HBV, HCV

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No