Ministry of food and drug safety

Ministry of food and drug safety

home > Our Works > Bio&Cosmetics > Manufactures
Manufactures|Bio&Cosmetics|Our Works|Minisry of Food and Drug Safety

Biological Products

(Cell therapy products) Tego Science, Inc
  • Registration Date 2017-02-27
  • Hit 3856

Company Information

1. Name

Tego Science, Inc

2. Website Address

http://www.tegoscience.com/ENG/

3. Location

93, Magokjungang 8-ro, Gangseo-Gu, Seoul 07794, Korea

4. Contacts

Email: swbaek@tegoscience.com

Tel: +82-2-818-2932

Fax: +82-2-2107-3173

Pharmaceutical Product Information

1. Brand Name

Holoderm®

2. Active Ingredient

Autologous Keratinocytes

3. Indication

1) Deep 2nd degree burn
2) 3rd degree burn

4. Information

* Introduction

Holoderm® is Korea's first and the world's second commercialized cultured skin autograft. A very small (1-3cm2) skin biopsy is taken from the patient suffering from a large 3rd degree burn wound, and the stem cells therefrom are cultured into sheet grafts, which are then transplanted on the patient's wound. Production takes 2-3 weeks, during which enough grafts can be obtained to cover the entire adult body surface. It is the most effective life-saver for a patient who has lost over 50% of his/her skin. Holoderm® has saved over 700 lives since 2002 and its usage is fully reimbursed by Korea's Workers' Compensation scheme.

* Summary Characteristics

-Autologous cell therapy drug to treat large deep 2nd and 3rd degree burns with dermal loss.
-Patient's own keratinocytes are cultured into epidermal sheets and transplanted back on his wound.
-One graft contains one to four billion regenerative stem cells.
-No immunological rejection and over 90% take rate in phase III clinical trial.

5. Images

Pharmaceutical Product Information

1. Brand Name

Kaloderm®

2. Active Ingredient

Allogeneic Keratinocytes

3. Indication

1) Deep 2nd degree burn
2) Diabetic foot ulcer

4. Information

* Introduction

Kaloderm® is an allogeneic epidermal cell sheet for healing wounds. It consists of cultured keratinocytes originated from the foreskin of a circumcised infant. We have the technology to propagate the cells almost indefinitely, meaning that Kaloderm® will always be made from the single source and maintain the same quality. Kaloderm® is mass-produced on a regular basis and can be stored frozen at -60°C for 24 months. Since the 2005 KFDA approval, 300,000 sheets have been used, mostly in burn clinics. We are continuing to upgrade its efficacy and expand its applications.

* Summary Characteristics

-A cell therapy drug composed of cultured human keratinocytes and indicated to treat deep 2nd degree burns and diabetic foot ulcers.
-The source cells derived from a Korean infant in 2001.
-Heals 40% faster than conventional dressing and minimizes scar formation.

5. Images

Pharmaceutical Product Information

1. Brand Name

Rosmir®

2. Active Ingredient

Autologous Fibroblasts

3. Indication

Improvement of nasojugal groove

4. Information

* Introduction

Rosmir® is a cell therapy product consisting of injectable autologous fibroblasts. Rosmir®, approved by MFDS in 2017, is the world’s first and only cell therapy indicated to improve nasojugal groove (a.k.a. tear trough). The manufacturing process takes 3 to 6 weeks starting with fibroblasts cultured from a small skin biopsy of an individual or frozen thereafter. Rosmir® is likely to work to improve wrinkles through secreting structural proteins and cytokines and thereby stimulating the proliferation of dermal cells.

* Summary Characteristics

- A cell therapy drug composed of autologous fibroblasts in single cell suspension and indicated to improve nasojugal groove.
- Rosmir® is manufactured from patients’ own fibroblasts from skin biopsy.
- In a clinical trial, 68.4% of Rosmir®-treated patients showed at least 2-grade improvement while none did in the control group.

5. Images



Attached File Attach all down

Division

Written by 박동현