Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa

An Open-label, Dose-escalation Study to Evaluate the Use of Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa

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).

Study Overview

• Status: Withdrawn
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: AMP-001 Low Dose; Drug: AMP-001 Medium Dose; Drug: AMP-001 High Dose

Detailed Description

Hidradenitis Suppurativa (HS) is a chronic inflammatory skin disease characterized by recurrent deep-seated boil-like abscesses and tracts under the skin. The most severe HS lesions are characterized by chronic non-healing sinuses, which form a wound-like environment as the abscesses heal; they produce significant skin scarring. Transcriptomic analysis of lesioned skin from HS patients suggests that it has similar pathology to other chronic wounds. IntegoGen's investigational product, IGN-AMP001, is manufactured from the amniotic membrane of the human placenta. The amnion membrane contains various cytokines and growth factors that promote wound healing. Local application of micronized dehydrated amnion membrane has been shown effective in treating chronic refractory non-healing dermal wounds of various etiologies in randomized clinical trials and case studies, which suggests it might be effective in treating HS wounds as well. Patients treated with IGN-AMP001 within IntegoGen associated clinics and other regenerative clinics have indicated positive responses. This study is designed to evaluate the safety, tolerability, and potential efficacy of IGN-AMP001 for HS.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77082
      • West Houston Dermatology Laser and Skin Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose AMP-001; 12.5 mg AMP-001 in 3 ml Saline	Drug: AMP-001 Low Dose; AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.; Other Names: 12.5 mg AMP-001
Experimental: Medium Dose AMP-001; 25 mg AMP-001in 3 ml Saline	Drug: AMP-001 Medium Dose; AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.; Other Names: 25 mg AMP-001
Experimental: High Dose AMP-001; 50 mg AMP-001 in 3 ml Saline	Drug: AMP-001 High Dose; AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.; Other Names: 50 mg AMP-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total number of Adverse Events	6 months

Collaborators and Investigators

• Sponsor: IntegoGen, LLC
• Investigators: Principal Investigator: Stephen Mahoney, MD, West Houston Dermatology Laser and Skin Care Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: INT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No