Regulatory Status and Safety

Regulatory Status:

Grafix® is a cryopreserved placental allograft tissue for acute and chronic wounds. Grafix is regulated as human cells, tissue, or cellular or tissue-based product (HCT/P) under 21 CFR part 1271 and section 361 of the Public Health Service (PHS) Act. Osiris Therapeutics, Inc. is registered with the FDA as a tissue establishment and accredited by the American Association of Tissue Banks (AATB).

  • Minimal manipulation
  • No synthetic carrier added
  • For homologous use
  • Stored frozen -75°C to -85°C
  • 2 year shelf life

Safety Profile:

  • Aseptic tissue processing
  • Antimicrobial treatment of tissue
  • Passes USP sterility testing

Donor Screening and Testing:

  • Medical and social history evaluation
  • Physical examination
  • Medical record evaluation
  • Licensed physician review of donor record
  • Human Immunodeficiency Virus Type 1 Antibody
  • Human Immunodeficiency Virus Type 2 Antibody
  • Hepatitis C virus antibody
  • Hepatitis B surface antigen
  • Hepatitis B core antibody (Total)
  • Syphilis by RPR, STS or equivalent
  • Human T-cell lymphotropic virus type I antibody
  • Human T-cell lymphotropic virus type II antibody
  • HIV nucleic acid (RNA) test
  • HCV nucleic acid (RNA) test
  • Acquired immunodeficiency syndrome (AIDS)
  • Group A streptococcus
  • Mycobacterium
  • Encephalitis
  • Epstein-Barr virus (mononucleosis)
  • Herpes virus
  • Hepatitis A
  • Meningitis
  • Poliomyelitis
  • Rabies
  • Varicella zoster
  • West Nile virus (WNV)
  • Bacteremia
  • Chagas disease
  • Condyloma
  • Clostridium difficile infection
  • Creutzfeldt-Jakob disease (CJD)
  • Encephalitis
  • Endocarditis
  • Gonorrhea
  • Histoplasmosis
  • Malaria
  • Meningitis
  • Methicillin-resistant Staphylococcus aureus (MRSA)
  • Osteomyelitis
  • Peritonitis
  • Pneumonia
  • Pyelonephritis
  • Rheumatic fever
  • Sepsis
  • Syphilis
  • Systemic mycoses
  • Tuberculosis
  • Urinary tract infection
  • Vancomycin-resistant Enterococcus (VRE)
  • Ankylosing spondilitis
  • Antiphospholipid syndrome
  • Autoimmune hemolytic anemia
  • Autoimmune lymphoproliferative syndrome
  • Autoimmune thrombocytopenic purpura
  • Autoimmune vasculitis
  • Celiac disease
  • Cold agglutinin disease
  • Crohn’s disease
  • Dermatomyositis
  • Goodpasture’s syndrome
  • Graves’ disease
  • Guillain-Barré syndrome
  • Hashimoto’s thyroiditis
  • Lupus erythematosis
  • Meniere’s disease
  • Mixed connective tissue disease
  • Multiple sclerosis
  • Myasthenia gravis
  • Pemphigus
  • Polyarteritis nodosa
  • Reactive arthritis (Reiter’s syndrome)
  • Rheumatoid arthritis
  • Sarcoidosis
  • Scleroderma
  • Sjogren’s syndrome
  • Vitiligo
  • Wegener’s granulomatosis
  • Adult respiratory distress syndrome (ARDS)
  • Alzheimer’s disease
  • Amyotropic lateral sclerosis (ALS)
  • Basal cell carcinoma
  • Burns
  • Cancer
  • Carbon monoxide poisoning
  • Chronic obstructive pulmonary disease (COPD)
  • Corneal scarring consistent with vaccinial keratinitis
  • Corticosteroid therapy
  • Cystic fibrosis
  • Diabetes mellitus
  • Disseminated lymphadenopathy
  • Emphysema
  • Eczema vaccinatum (lesion or scab)
  • Genetic disease
  • Hemophilia
  • Huntington’s disease (or chorea)
  • Idiopathic thrombocytopenic purpura
  • Kaposi’s sarcoma
  • Leukemia
  • Marfan’s syndrome
  • Multiple myeloma (plasmacytoma)
  • Muscular dystrophy
  • Myelodysplastic syndrome
  • Parkinson’s disease
  • Polycythemia vera
  • Rash, generalized vesicular/vaccinia
  • Sickle cell anemia
  • Vaccination
  • Vaccinia
   
  • This field is for validation purposes and should be left unchanged.

Take Your First Step in a New Direction

To learn more about Grafix, or to place an order, please contact us directly.

Address:
7015 Albert Einstein Drive
Columbia, MD 21046
Customer Service: (866) 352-4540
Fax: (443) 545-1701

For general product information or to place an order, contact: Biosurgery@osiris.com