Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa

This is an interventional treatment trial for Hidradenitis Suppurativa Read More

Inclusion Criteria:

• Age ≥18 years
• Can understand the nature of the procedure, and provide, or have a legal representative provide, a written informed consent.
• Clinically diagnosed with Hidradenitis Suppurativa characterized as Hurley Score, Stage II or Stage III.
• History of standard-of-care supportive treatment failure with corticosteroids and/or antibiotics within 30 days before the baseline visit.
• Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit.
• No prior history of a biologic product or Humira for the treatment of Hidradenitis Suppurativa.

Exclusion Criteria:

• Intolerance or unwillingness to participate in all procedure(s) or medication(s) required of this protocol.

• Diagnosis or reported history of any of the folding conditions:

  1. Uncontrolled Diabetes Mellitus (HbA1c ≥9);
  2. Severe Morbid Obesity (BMI≥40);
  3. Chronic heart, renal, or hepatic disease;
  4. Neurodegenerative debilitating conditions, and
  5. Cancer.
• The participant is currently receiving or has received within 3 months before enrollment, medications or treatments that are known to affect the wound healing process, including but not limited to: chronic systemic steroid intake, history of recent changes in the participant's tissue integrity (i.e., thin, fragile skin with multiple hematomas or previous lacerations), current use of immune-suppressive drugs, radiation therapy, immunomodulating medications, and chemotherapy.
• The participant has received HS micronized amnion therapy in the last 90 days.
• Systolic blood pressure greater than 190 or less than 90 mmHg.
• Diastolic blood pressure greater than 105 or less than 50 mmHg.
• Early, symptomatic autonomic dysfunction.
• Abuse of prescription drugs, illegal substances, and/or alcohol.
• Females who are pregnant, nursing, or of childbearing potential and not using a reliable birth control method (such as, female use of a diaphragm, intrauterine device (IUD), or contraceptive sponge or gels, in addition to male use of a condom) or the female should be using prescribed "birth control" pills, injections, or implants. or who intend to become pregnant during their participation in the study.
• Clinically significant abnormal laboratory values at the time of the screening or baseline visit.
• Exposure to the investigational product within 3 months prior to enrollment or anticipate participation in any other investigational drug study or other interventional studies while enrolled in the study.
• In the opinion of the Principal Investigator, the participant should not be enrolled in the study.