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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

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

Protocol Number: ST266-CRS-101, open and enrolling

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.

ST266 Eye Drops for the Treatment of Persistent Corneal Epithelial Defects
Protocol Number: ST266-PED-201, completed.

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