Allogeneic Micronized Amniotic Membrane Product 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.