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Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04541550
Recruitment Status : Withdrawn (Study didn't proceed to FDA submission)
First Posted : September 9, 2020
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
IntegoGen, LLC

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: AMP-001 Low Dose Drug: AMP-001 Medium Dose Drug: AMP-001 High Dose Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Dose-escalation Study to Evaluate the Use of Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: 50 mg AMP-001


Outcome Measures
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Primary Outcome Measures :
  1. Total number of Adverse Events [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541550


Locations
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United States, Texas
West Houston Dermatology Laser and Skin Care Center
Houston, Texas, United States, 77082
Sponsors and Collaborators
IntegoGen, LLC
Investigators
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Principal Investigator: Stephen Mahoney, MD West Houston Dermatology Laser and Skin Care Center
More Information
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Responsible Party: IntegoGen, LLC
ClinicalTrials.gov Identifier: NCT04541550    
Other Study ID Numbers: INT-001
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration