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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.

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 open for enrollment

Study of ST266 Given by Intranasal Delivery in Subjects With Ocular Hypertension
Protocol Number: ST266-IOPHTN-101, open and enrolling

A dose-escalating phase 1 open-label safety study of ST266 given by non-invasive intranasal trans-cribriform delivery in subjects with increased intraocular pressure without evidence of glaucomatous damage.

Inclusion criteria:
  1. Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act) document.
  2. Male or Female, Ages 20-75 years.
  3. Must have mildly elevated intraocular pressure (IOP) without evidence of glaucomatous damage.
  4. IOP ≤ 28 mmHg and at least one (1) IOP measurement > 21 mmHg.
  5. Normal visual fields (VF) both Swedish Interactive Threshold Algorithm – Short-wavelength Automated Perimetry (SITA-SWAP) and 24-2 VF spaced at least six (6) months apart.
  6. Normal Ocular Coherence Tomography (OCT) (of macula and nerve fiber layer) spaced at least six (6) months apart.
  7. Gonioscopy open to at least scleral spur with normal iris configuration.
  8. Normal baseline neuro-cognitive testing.
  9. Normal baseline Magnetic Resonance Imaging (MRI), including expected age-related changes, performed with and without contrast.
  10. Baseline Lumbar Puncture within normal limits.
Exclusion criteria:
  1. Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act) document.
  2. Male or Female, Ages 20-75 years.
  3. Must have mildly elevated intraocular pressure (IOP) without evidence of glaucomatous damage.
  4. IOP ≤ 28 mmHg and at least one (1) IOP measurement > 21 mmHg.
  5. Normal visual fields (VF) both Swedish Interactive Threshold Algorithm – Short-wavelength Automated Perimetry (SITA-SWAP) and 24-2 VF spaced at least six (6) months apart.
  6. Normal Ocular Coherence Tomography (OCT) (of macula and nerve fiber layer) spaced at least six (6) months apart.
  7. Gonioscopy open to at least scleral spur with normal iris configuration.
  8. Normal baseline neuro-cognitive testing.
  9. Normal baseline Magnetic Resonance Imaging (MRI), including expected age-related changes, performed with and without contrast.
  10. Baseline Lumbar Puncture within normal limits.

ST266 Eye Drops for the Treatment of Persistent Corneal Epithelial Defects Protocol Number:
ST266-PED-201, open and enrolling

A phase 2 open-label trial of ST266 eye drops in the treatment of persistent corneal epithelial defects (PED).

Inclusion criteria:
  1. Male and female subjects aged 18 years and over.
  2. Subjects with a PED present for at least seven (7) days.
  3. The defect may be of any size and must be measurable by slit lamp.
  4. In the Investigator's opinion, the defect is persistent (ie, the defect has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses).
  5. The original defect to the cornea must be hard to heal and be a result of any injury, infection, disease or surgery to the eye.
Exclusion criteria:
  1. Subjects who are currently being treated with cenegermin.
  2. Subject who requires treatment with autologous serum eyedrops throughout the duration of the trial. If, in the opinion of the investigator, autologous serum eyedrop treatment can be safely stopped, subject may be included in the clinical trial.
  3. Subject who requires treatment with other amnion products throughout the duration of the trial. If, in the opinion of the investigator, the amniotic product treatment can be safely stopped, subject may be included in the clinical trial.
  4. Subject who requires treatment with amniotic membrane throughout the duration of the trial. If the amniotic membrane can be safely stopped, the subject may be included in the clinical trial. Note: The amniotic membrane must be removed at least one (1) day prior to the baseline visit.
  5. Subject has had an uncontrolled lid or ocular infection.
  6. History of alkali burns of the cornea.
  7. The circumference affected by limbal blood vessel ischemia is greater than 75 percent of the circumference.
  8. Subjects with severe lid abnormalities contributory to the persistence of the PED such as the inability to close the lids.
  9. Subjects who have a history of AIDS or HIV.
  10. Treatment with systemic corticosteroids (equivalent to >10 mg/day of prednisone) or immunosuppressive (including Plaquenil) or chemotherapeutic agents within 7 days prior to Day 1, or likely to receive one of these therapies during study participation.
  11. Subjects who have participated in a clinical trial within 30 days prior to Day 1.
  12. Subjects with more than one distinct PED in the study eye.
  13. Subjects with bullous keratopathy.
  14. Subjects with corneal perforation or impending corneal perforation.
  15. For subjects with bilateral PEDs, only the eye with the larger PED should be entered in to the study. The non-study eye will receive standard of care treatment and will be observed throughout the trial.
  16. Female subjects who are pregnant or breastfeeding. Female subjects who are neither postmenopausal nor surgically sterile require a negative urine pregnancy test on Day 1 visit.
  17. Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Mooren's ulceration.
  18. Subjects with recurrent corneal erosion.