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

ST266 Eye Drops for the Treatment of Persistent Corneal Epithelial Defects

Protocol Number: ST266-PED-202, open and enrolling

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension to Evaluate the Safety and Efficacy of ST266 Eye Drops in the Treatment of Persistent Corneal Epithelial Defects

Inclusion criteria:
  1. Male and non-pregnant/non-breastfeeding female subjects aged 18 years and older.
  2. Subjects with a PED present for at least seven (7) days at the time of Screening.
  3. The defect must be at least 1.0 mm (longest linear measurement) at Screening and Baseline (Day 1) and must be measurable by slit lamp.
  1. In the Investigator's opinion, the defect is persistent i.e., the defect has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses.
  2. The original defect to the cornea must be the result of an injury, infection, disease, or surgery to the eye.
Exclusion criteria:
  1. Subjects currently being treated with cenegermin or other rhNGF in the study eye.
  2. Subjects currently using topical antibiotic eye drops in the study eye. Subjects on current antibiotic therapy must be willing to switch to study-provided moxifloxacin.
  3. Subjects currently taking topical steroids or corticosteroid-containing eye drops or ointment in the study eye. Subjects currently taking systemic corticosteroids with a dose of >10mg/day prednisone or equivalent.
  4. Subjects currently using topical antihistamine eye drops or vasoconstrictors in the study eye.
  5. Subjects currently using topical or local immunosuppressive agents (e.g., optic cyclosporine or liftegrast) in the study eye.
  6. Subjects who require treatment with autologous serum eyedrops or amnion products in the study eye.
  7. Subjects who need to use contact lenses for refractive correction during the study.
  8. Subjects who require treatment with bandage contact lens or punctal plugs in the study eye that cannot be removed.
  9. Subjects currently taking antiviral medications for an active infection in the study eye. Subjects taking antiviral medications for prophylaxis may be enrolled in the study at the Investigator’s discretion, provided that the subject remain on a stable dosing regimen throughout the duration of the study.
  10. History of ocular surgery (including laser or refractive surgery) in the study eye within 3 months prior to study screening.
  11. Subjects with an uncontrolled lid or ocular infection in the study eye.
  12. History of alkali burns of the cornea.
  13. The circumference affected by limbal blood vessel ischemia is greater than 75 percent of the limbal circulation.
  14. Subjects with severe lid abnormalities contributory to the persistence of the PED such as inability to close the lids.
  15. Subjects who have a history of AIDS or HIV.
  16. Subjects who have participated in a clinical trial (including a previous study involving ST266) within 30 days prior to Day 1.
  17. Subjects who have more than one distinct PED in the study eye prior to screening visits. Subjects who develop PEDs after the screening visit will remain in the study; however, only the original study PED will be assessed.
  18. For subjects with bilateral PEDs, only the eye with the larger PED should be entered into the study. The non-study eye will receive standard of care treatment and be observed throughout the trial.
  19. Subjects with bullous keratopathy in the study eye.
  20. Subjects with corneal perforation or impending corneal perforation in the study eye.
  21. Subjects with uncontrolled glaucoma.
  22. Female subjects who are pregnant or breastfeeding. Female subjects who are neither postmenopausal for at least 1 year nor surgically sterile require a negative urine pregnancy test. All subjects must use an acceptable form of birth control during the study such as abstinence, barrier method, or hormonal contraceptive.
  23. Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Mooren's ulceration.
  24. Subjects with recurrent corneal erosion or corneal basement membrane dystrophy.
  25. Known hypersensitivity to study provided lubricating drops, antibiotic drops, and/or procedural medications such as fluorescein dye.

Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ST266.

Safety and Tolerability of Intravenous ST266 in Subjects with Confirmed COVID-19 Infection

Protocol Number: ST266-CRS-101, enrollment now closed

A Phase 1, Multi-Center, Open-Label, Safety and Tolerability Study of Intravenous Administration of ST266 in Subjects with confirmed COVID-19 infection

Inclusion criteria:
  1. Males and non-pregnant/non-breastfeeding females age 18-70 years of age.
  2. Laboratory confirmed SARS-CoV-2 infection determined by PCR or other commercial/public health assay (test results must be obtained during the 7-day screening visit window).
  3. BMI between 18 and 39 inclusive, with a maximum weight of 150 kg (330lbs).
  4. Asymptomatic or mildly symptomatic COVID-19 positive subject with a score of 1 or 2 on the WHO 7-point ordinal scale
    1. Not hospitalized, no limitation on activities;
    2. Not hospitalized, limitation on activities;
    3. Hospitalized, not requiring supplemental oxygen;
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    6. Hospitalized, on invasive mechanical ventilation or ECMO;
    7. Death.
  5. Subjects with pulse oximetry of > 94% on room air
  6. Subjects have controlled blood pressure of 90 mmHg (or 20 mmHg less than usual range, whichever is higher)
  7. Subjects with pulse < 120 bpm
  8. Willingness and ability to comply with study-related procedures and assessments.
  9. If female, subjects must use an effective method of birth control or abstain from sexual relations with a male partner (unless has undergone tubal ligation or is 1 year postmenopausal) for their duration of study participation.
  10. If male, subjects must use an effective method of birth control or abstain from sexual relations with a female partner (unless has undergone a vasectomy and it has been more than 6 months) for their duration of study participation.
  11. Subject or subject’s legal representative provides written consent prior to the initiation of any Screening or study specific procedures.
Exclusion criteria:
  1. Subjects requiring immediate admission to the hospital due to complications of COVID-19 infection.
  2. Subject has an untreated active systemic bacterial, fungal, viral or other infection not related to COVID-19 infection.
  3. Subjects with chronic lung diseases of any etiology including idiopathic pulmonary fibrosis, Tuberculosis, COPD, persistent asthma, and pulmonary hypertension.
  4. Subjects with a severe history of cardiac disease (such as congestive heart failure, coronary artery disease, cardiac arrythmia)
  5. Subjects with a history of neurological disorders (such as epilepsy, stroke, encephalopathy, Guillain-Barré syndrome)
  6. Subjects with D-dimer > 2 ug/mL
  7. Subjects with fibrinogen > 5g/L
  8. Subjects with a history of coagulopathy or currently taking anti-coagulation medication
  9. Subjects with PTT ≥ 100s or INR ≥ 2.75
  10. Malignancy in the last 5 years (except successfully treated basal cell carcinoma).
  11. Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR < 30).
  12. Subjects with a reactive or positive screening test result For Hepatitis A virus immunoglobulin M (HAV IgM), Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus Antibody (HCVAb) or Human Immunodeficiency Virus Antibody (HIVAb).
  13. TBIL> 2×ULN, ALT > 3×ULN, AST> 3×ULN, or ALP> 3×ULN.
  14. Neutrophils <1000/mm3, PLT<50×10^9/L, or HGB<8g/L
  15. Previous participation in any other clinical trial for the treatment for COVID-19.
  16. Subject actively participating in any other clinical study (with the exception of observational studies where there is no intervention with an investigational product or device)
  17. Use of anti-cancer or immunomodulatory biological drug or kinase inhibitor (e.g., tocilizumab, sarilumab) or, JAK inhibitors (within 30 days of enrollment or five times the half-life [whichever is longer]).
  18. Chronic glucocorticosteroid use equivalent to daily oral prednisone > 10 mg per day (10 mg oral prednisone every other day is allowed).
  19. Live (live-attenuated) vaccines are not permitted within 2 weeks prior to enrollment or during the study treatment and safety follow-up periods (with the exception of the Flu vaccine which is allowed at any time)
  20. Subject is pregnant or breastfeeding or plans to become pregnant within 12 months.
  21. Subjects with a history of alcohol or drug abuse or dependence, or the use of illicit drugs such as medical marijuana within the 12 months prior to Screening.
  22. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.

Study of ST266 Given by Intranasal Delivery in Glaucoma Suspect Subjects

Protocol Number: ST266-IOPHTN-101, enrollment closed.

A dose-escalating phase 1 open-label safety study of ST266 given by non-invasive intranasal trans-cribriform delivery in glaucoma suspect subjects with increased intraocular pressure, optic nerve cupping, or family history of glaucoma 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 be clinically followed as a glaucoma suspect without evidence of glaucomatous damage.
  4. Must have one of the following: 1) IOP ≤ 28 mmHgand at least one (1) IOP measurement > 21 mmHg, or 2) physiologic cupping of the optic nerve, or 3) a family history of glaucoma.
  5. Two (2) normal visual fields (VF) both Swedish Interactive Threshold Algorithm – Short-wavelength Automated Perimetry (SITA-SWAP) and 24-2 VF
  6. Two (2) normal Ocular Coherence Tomography (OCT) (of macula and nerve fiber layer).
  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. Cohort Three group only: baseline Lumbar Puncture within normal limits.
Exclusion criteria:

Each subject must not be:

  1. Females of Child Bearing Potential (FOCBP) who are pregnant or lactating or who will not abstain from sexual activity for 14 days prior to Visit 1, and willing to remain so through 30 days following completion of the subject’s first menstrual cycle following the End of Treatment (EOT) Visit. Alternatively, a WOCBP who will not remain abstinent must have been using one of the following acceptable methods of birth control for the times specified:
    • IUD in place for at least three (3) months prior to Visit 1 until completion of the subject’s first menstrual cycle following the EOT Visit.
    • Barrier method (condom or diaphragm) with spermicide for at least three (3) months prior to Visit 1 through completion of the subject’s first menstrual cycle following the EOT Visit.
    • Stable hormonal contraceptive for at least three (3) months prior to Visit 1 through completion of the subject’s first menstrual cycle following the EOT Visit.
      • NOTE: For Depo-Provera injection contraceptives, the statement regarding first menstrual cycle following administration of the study product is not applicable as females receiving this form of contraception will not have menses. 
    • In a monogamous relationship with a surgically sterilized (i.e., vasectomized) partner at least six (6) months prior to Visit 1.
    • Have undergone one (1) of the following sterilization procedures at least six (6) months prior to Visit 1: Bilateral tubal ligation, Hysterectomy, Hysterectomy with unilateral or bilateral oophorectomy, Bilateral oophorectomy.
  2. Unwillingness to submit a urine pregnancy test at screening if of childbearing potential.
  3. Male subjects who refuse to use one of the following birth control methods:
    • Abstinence from the time of consent and through the duration of their participation in the protocol
    • Barrier method (condom or diaphragm) with spermicide from time of consent through the duration of their participation in the protocol
    • Surgical sterilization (vasectomy) at least six (6) months prior to consent.
  4. IOP greater than 29 mmHg in either eye.
  5. Subjects with high risk factors of ocular hypertension, such as thin central corneas, as identified by the Principal Investigator who may benefit from earlier treatment will be excluded.
  6. Evidence of Angle closure.
  7. Recent laser or incisional glaucoma surgery.
  8. Subjects who are currently taking glaucoma medications. Subject who can safely stop taking these medications during washout period (4-6 weeks) may be considered.
  9. Intranasal polyp or any head and/or neck neoplasm.
  10. History of or evidence on physical examination including endoscopy of sinus or nasal pathology, nasal passage obstruction, chronic sinus infections, or severe seasonal allergies.
  11. Currently using medications given intranasally.
  12. Subject is taking any anticoagulant medication such as heparin, low molecular weight heparin, Coumadin, or antiplatelet agents including low dose aspirin.
  13. History of stroke or Trans-Ischemic Attack (TIA) within the past five (5) years.
  14. Neuro-cognitively impaired as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
  15. Subjects who have participated in an investigational product trial within the past 30 days.
  16. Subjects who refuse any part of the protocol assessments.