Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04541550
Other study ID # INT-001
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date April 1, 2021
Est. completion date July 1, 2021

Study information

Verified date September 2021
Source IntegoGen, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
AMP-001 Low Dose
AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.
AMP-001 Medium Dose
AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.
AMP-001 High Dose
AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.

Locations

Country Name City State
United States West Houston Dermatology Laser and Skin Care Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
IntegoGen, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total number of Adverse Events 6 months
See also
  Status Clinical Trial Phase
Completed NCT02904902 - Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa Phase 3
Completed NCT03628924 - A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 2
Not yet recruiting NCT05531747 - Replicative Stress in Hair Follicle Stem Cells and Pathogeny of Hidradenitis Suppurativa N/A
Recruiting NCT06028230 - A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Phase 2
Completed NCT03275870 - Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa Phase 1/Phase 2
Completed NCT03248531 - A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa. Phase 2
Withdrawn NCT04100083 - Spironolactone for Hidradenitis Suppurativa Phase 4
Completed NCT00329823 - Etanercept in Hidradenitis Suppurativa Phase 2
Recruiting NCT05710393 - Hidradenitis - an Analysis of Genetic Traits and Linkages in Families
Completed NCT04019041 - A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa Phase 2
Completed NCT05286567 - A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa. Phase 1
Withdrawn NCT03929835 - Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa Phase 2
Terminated NCT04325607 - Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa N/A
Terminated NCT03238469 - Microwave Ablation in Mild Axillary Hidradenitis Suppurativa N/A
Completed NCT04449354 - HidraWear AX HS Study N/A
Recruiting NCT06123429 - Mindfulness in Hidradenitis Suppurativa N/A
Recruiting NCT05934825 - Clinical Trial to Evaluate Safety and Efficiency of Mesenchymal Stem Cell in Patients With Hidradenitis Suppurativa Phase 1/Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT06046729 - A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Phase 2
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2