Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa
Withdrawn before enrolling · Phase 1
Conditions studied: Hidradenitis Suppurativa
In brief
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).
Key facts
- Study ID
- NCT04541550
- Run by
- IntegoGen, LLC
- People needed
- 0
- Starts
- 2021-04-01
- Expected to finish
- 2021-07-01
- Last updated by the study team
- 2021-09-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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:
- Uncontrolled Diabetes Mellitus (HbA1c ≥9);
- Severe Morbid Obesity (BMI≥40);
- Chronic heart, renal, or hepatic disease;
- Neurodegenerative debilitating conditions, and
- 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.
Where it is running
- West Houston Dermatology Laser and Skin Care Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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