RegeneRx

Am I Eligible?

Eligibility:

Ages Eligible for Study: 2 years of age or older
Genders Eligible for Study: Both

Inclusion Criteria:

  • Informed Consent Form signed by the patient or patient's legal representative; also, if the patient is under the age of majority but capable of providing assent, signed assent from the patient
  • Diagnosis of junctional or dystrophic EB.
  • Patients who present with Hallopeau-Siemens subtype may be enrolled.
  • At least one active, unroofed EB erosion on the limb or on the trunk.
  • Lesion size 5 to 50 cm2, inclusive.
  • Stable lesion present for 14-60 days before enrollment.

Exclusion Criteria:

  • Clinical evidence of local infection of the index (targeted) lesion.
  • Use of any investigational drug within the 30 days before enrollment.
  • Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment.
  • Clinically significant abnormalities on Screening laboratory tests, except for the following specific laboratory threshold result:
    - albumin <2.0 g/dL.
    - hemoglobin < 8 g/dL
  • Use of systemic or topical steroidal therapy within the 30 days before enrollment. (except inhaled steroids)
  • Use of systemic antibiotics within the 7 days before enrollment.
  • Current or former malignancy.
  • Arterial or venous disorder resulting in ulcerated wounds.
  • Diabetes mellitus.
  • Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)