the vision to heal

Clinical trials

ST266 is a non-cellular biologic drug candidate, currently considered “investigational,” since it is not yet approved by the U.S. Food and Drug Administration (FDA). Our clinical trials are designed to examine and confirm that ST266 is safe and effective in humans with the goal of bringing this unique product to potentially millions of patients who suffer from complex diseases and conditions in ophthalmology, neurology, dermatology—and beyond.

ST266 is made by our proprietary method of culturing amnion epithelial cells that are harvested from donated full-term placentas normally discarded after birth. It contains hundreds of biologically active proteins and other factors crucial to neuroprotection, the modulation of inflammation, cell recovery and healing. These various proteins and factors are delivered in physiologic concentrations that have been shown, in preclinical and clinical studies to date, to be well-tolerated with demonstrated biologic activity.

In clinical trials, 270 patients have been administered St266 by topical dermal, topical oral, topical ocular, intravenous, and targeted intranasal delivery with no reported drug-related serious adverse events.

Enrollment in one of our clinical trials is the only way we can provide access to our investigational drugs prior to their FDA approval. Patients who choose to participate in a clinical trial are playing an important role in helping advance new medical breakthroughs.

Current trials

Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis

Protocol Number:        ST266-NEC-201, Open and Enrolling

Randomized, Controlled, Phase 1-2 Open Label Study of ST266 IV Administration to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis


Inclusion criteria:
  1. Premature (≥26 and ≤36 weeks gestational age) infant weight between ≥800g and ≤3000g. Parent(s)/legal medical representative(s) voluntarily provides written consent prior to study enrollment.
  2. Minimum Bell stage IIA NEC diagnosis by radiologic confirmed pneumatosis intestinalis and may include intestinal dilation and ileus.
Exclusion criteria:
  1. Infants with abdominal perforation at less than 10 days of life
  2. Not expected to survive ≥2 weeks or born with a lethal condition requiring hospice or palliative care.
  3. Born with major congenital anomalies such as cardiac defects (e.g., Tetralogy of Fallot) or chromosomal disorders/anomalies (e.g., neural tube defect).
  4. Mother's receipt of any investigational product during pregnancy.
  5. Infants with malignancies.
  6. Infants with hypercoagulability disorders (any active thrombosis, diagnosis of disseminated intravascular coagulation or other acquired/inherited disorders (i.e., hemophilia) of coagulation.
  7. Infants with a known immunodeficiency (such as galactosemia or agranulocytosis).
  8. Infants with anatomic defects that require surgical intervention.
  9. Infants with persistent pulmonary hypertension of newborn.
  10. Infants with any congenital or acquired gastrointestinal pathology that preclude feeds within 7 days after birth (e.g., duodenal atresia).
  11. Infants who have hypoxic ischemic injury (perinatal asphyxia).
  12. Infants with polycythemia (at time of treatment) (>22 g/dL).
  13. Positive maternal human immunodeficiency virus status.
  14. History of maternal drug abuse.

15.  Considered by the Investigator, for any reason, to be an unsuitable candidate for the study.