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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.

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. 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.