Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-24 @ 4:53 PM
Study NCT ID:
NCT04541550
Status:
WITHDRAWN
Last Update Posted:
2021-09-08
First Post:
2020-09-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa
Sponsor:
IntegoGen, LLC
Organization:
Study Overview
Official Title:
An Open-label, Dose-escalation Study to Evaluate the Use of Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study didn't proceed to FDA submission
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: