Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa

• Status: Withdrawn
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open-label, dose-escalation study enrolling 15 participants.

There are 3 cohorts:

1. Cohort I: 5 subjects each receiving 1 injection of IGN-AMP001 (12.5mg AMP-001 in 3ml Saline)

2. Cohort II: 5 subjects each receiving 1 injection of IGN-AMP001 (25 mg AMP-001 in 3 ml Saline)

3. Cohort III: 5 subjects each receiving 1 injection of IGN-AMP001 (50 mg AMP-001 in 3 ml Saline).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IntegoGen, LLC

Criteria

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.