Therapy Products

PRODUCT / Therapy Products

KeraHeal

A Spray-Type Autologous Keratinocyte Therapy
Product for Wounds

Product Name KeraHeal
Indications Deep 2nd degree burns that cover more than 30%
of the total body surface area
3rd degree burns that cover more than 10%
of the total body surface area
Dosage 1 mL cell suspension / 100~400 cm2
Storage Refrigerated at 2~8℃

※ Visit http://ezdrug.mfds.go.kr/ for more information

Therapeutic Effects of KeraHeal

Engraftment
Rate (%)
KeraHeal Number of Patients
99.7% 10
100.0% 29
68.0% 16
Survival
Rate (%)
74.3%
(59.3% Without KeraHeal)
35

References

  • Journal of Korean Burn Society. 2007;10(2):112-7. Clinical Study of Autologous Cultured Keratinocyte Cell Spray "KerahealTM" on Severe Burn Wound.
  • Burns. 2011 Sep;37(6):1067-71. Clinical study of cultured epithelial autografts in liquid suspension in severe burn patients.
  • Burns. 2012 Sep;38(6):931-6. Outcomes of sprayed cultured epithelial autografts for full-thickness wounds: a single-centre experience.
  • Wound Repair Regen. 2015 May-Jun;23(3):340-4. The application of cultured epithelial autografts improves survival in burns.

  • Human Epidermal Keratinocytes

  • Expression of p63
    (A Marker for Skin Stem Cells)

KeraHeal-Allo

A Thermosensitive Hydrogel-Type Allogeneic
Keratinocyte Therapy Product

Product Name KeraHeal-Allo
Indications Promotes the re-epithelialization of deep 2nd degree burns
Dosage 1.5 mL cell suspension(2×107 cells) / 100 cm2
Storage Frozen at -15 ~ -25℃
Shelf Life 18 months from production

※ Visit http://ezdrug.mfds.go.kr/ for more information

Therapeutic Effects of KeraHeal-Allo
(When Compared to Silicon Dressing)

Duration of
Re-epithelialization
(days)
KeraHeal-Allo
(N=30)
Mepitel
(N=30)
KeraHeal-Allo
(N=15)
Mepitel
(N=15)
11.5 ± 4.3 14.1 ± 4.3 9.6 ± 4.0 12.4 ± 4.8
〈0.0001 〈0.0001

References

  • Clinical Trial Reports for KeraHeal-Allo
  • Burns. 2014 Dec; 40(8): 1642-9. A clinical trial designed to evaluate the safety and effectiveness of a thermosensitive hydrogel-type cultured epidermal allograft for deep second-degree burns.

CartiLife

Autologous chondrocyte derived cartilaginous cell therapy for structural restoration of cartilage defect and symptom alleviation

회사개요
Product CartiLife (BiSol autologous chondrocyte cells)

Ingredients and Quantity

In one 3mL vial, Active ingredient : BiSol Autologous Keratinocyte Cells (2.0 ~ 5.0x107 cells) Additives (suspending agents) : Phenol Red Free High glucose Dulbecco’s Modified Eagle Medium 3 mL
Therapeutic effects Treatment of Knee cartilage defects (ICRS Grade 3 or 4, defect area 2 ~ 10 cm2)
Application method and dosage Implant
Storage method Sealed container 2~8℃

※ Refer to http://ezdrug.mfds.go.kr/ for more information.

CartiLife's therapeutic effect

Structural improvement compared to Control group (MRI, MOCART Score) (Phase 2)

MRI (Phase 1)

Improvements on symptom, function and pain (Phase 1).

Subjective IKDC Score
Lysholm Score
Tegner Activity Score