Advanced Amnion-Chorion Skin Substitutes for Chronic Wound Healing

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Advanced Amnion-Chorion Skin Substitutes for Chronic Wound Healing.

Transforming wound care with biological solutions that accelerate healing while minimizing complications for diabetic foot ulcers, venous leg ulcers, and other chronic wounds.

reduction in wound infection rates

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faster healing with certified teams

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staff retention with LEAD framework

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improvement in healing rates

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Understanding

Cellular and Tissue-Based Products (CTPs)

Advanced wound care solutions that leverage the unique properties of placental tissue to effectively address the diverse and complex challenges associated with chronic wounds, ensuring better healing outcomes and improved patient care.

The $20 billion wound care market is gaining ground, driven in part by the emerging Cellular and Tissue Based Products (CTP) sector.

This market refers to an array of bioengineered and synthetic products derived from various sources that promote wound closure and healing.

Currently estimated at $3.4 billion, the advanced wound care market is projected to reach nearly $5 billion by 2027, an annual growth rate of 9.9% from 2020 to 2027.

Why Focus on These Products?

65% of wounds encompass three main conditions – Diabetic, Pressure, and Venous Ulcers.

The estimated annual cost burden for care of diabetic foot disease is $18.7 billion for Medicare recipients, and approximately $80 billion for overall treatment across all age groups.

Amnion-Chorion Membranes

Biological Properties

Understanding the regenerative mechanisms that make cellular tissue products effective for chronic wound healing.

Complex Extracellular Matrix

The amnion’s extracellular matrix is rich in collagen types I, III, IV, and VII, fibronectin, and laminin, which provide structural support for cell migration and angiogenesis.

Growth Factor Content

Chorionic membranes contribute additional growth factors such as FGF, EGF, and TGF-β which regulate inflammation, stimulate tissue repair and new growth.

Low Immunogenicity

The amnion lacks HLA-A, B, and DR antigens, minimizing rejection risk, while chorion contains regulatory cytokines like IL-10 that suppress dendritic cell activation.

Antimicrobial Protection

Antimicrobial peptides such as defensins and elafin in amniotic fluid confer intrinsic antibacterial properties, reducing infection rates in chronic wounds.

Dehydration and cryopreservation techniques preserve these biological attributes while extending shelf life, enabling off-the-shelf availability for clinical use.

Clinical Effecacy

Across Wound Types

Evidence-based outcomes have been established for a variety of chronic wounds, highlighting the importance of employing biomedical research and clinical studies to guide effective treatment strategies.

DFUs, characterized by impaired angiogenesis and persistent inflammation, benefit uniquely from amnion-chorion substitutes. The hypoxic wound microenvironment in diabetes is ameliorated by placental membranes’ oxygen-carrying capacity, while angiogenic factors like vascular endothelial growth factor (VEGF) stimulate capillary formation.

VLUs, often complicated by edema and fibrinous exudate, require therapies that withstand mechanical stress while modulating inflammation. CTPs provide the mechanical strength and biological signaling needed to address these complex wounds.

Research Studies

Key Clinical Trials Overview

Comprehensive analysis of randomized controlled trials and comparative studies supporting the efficacy of amnion-chorion products

DEBTAL Trial

n=168 • 24-week

Objective: Compare acellular dermal matrices (ADMs) against standard care for DFUs
Methods: Multicenter RCT with 24-week follow-up period
Key Finding: Single applications of DermACELL® (amnion-chorion matrix) achieved 65% closure at 12 weeks versus 41.1% for standard care
p-Value: p<0.001
Walters et al. (2016), Int Wound J, 13(6):1111-1120

Snyder VLU Study

n=109 • 12-week

Objective: Evaluate dHACM as an adjunct to compression therapy for venous leg ulcers
Methods: 12-week randomized clinical trial with standard compression
Key Finding: dHACM plus compression therapy achieved 60% closure rate versus 35% for compression alone
Significance: Attributed to membrane's metalloproteinase inhibition and TGF-β3-mediated fibrotic regulation
Snyder et al. (2016), J Wound Care, 25(7):S22-S28

Zelen Comparative Study

n=100 • Multi-center

Objective: Compare dehydrated human amnion/chorion membrane (dHACM) with bilayered living cellular construct (BLCC)
Methods: Prospective, randomized, controlled multicenter clinical trial
Key Finding: 97% DFU closure with weekly dHACM versus 73% for BLCC, with median closure times of 23.6 versus 34 days
p-Value: p=0.0498
Zelen et al. (2014), Int Wound J, 13(6):1271-1277

Tettelbach DFU Study

n=110 • RCT

Objective: Evaluate efficacy of dHACM allograft for chronic DFUs
Methods: Prospective, randomized, controlled, multi-center clinical trial
Key Finding: dHACM showed 70% complete healing at 12 weeks vs. 50% for standard care alone
Hazard Ratio: 2.15 (95% CI 1.30-3.57)
Tettelbach et al. (2019), Int Wound J, 16(1):122-130

Meta-Analyses

Cost-Effectiveness Evidence

Comparative Cost Analysis

Methodology: 2019 cost-utility analysis (n=120 VLUs)

Result: SIS-amnion composite grafts reduced total treatment costs by 31% over 6 months due to fewer dressing changes and outpatient visits

ICER: $18,450 per QALY for dHACM in DFUs (below $50,000/QALY threshold)

Long-Term Economic Impact

Reduction in:

Hospital readmissions
Amputation rates
Nursing time
Overall treatment duration

Ongoing Clinical Trials

AMSC-Seeded Matrices (NCT04889213)

Status: Phase II, Recruiting

Focus: Evaluating AMSC-seeded chorion matrices for neuropathic DFUs

Preliminary Data: 89% closure at 16 weeks vs. 52% for acellular grafts

AI-Driven Customization (MultiTech-034)

Status: Pre-registration

Design: Adaptive platform trial using machine learning algorithms

Innovation: Matching dHACM variants to ulcer microenvironments based on proteomics

Expected Completion: Q4 2025

Strength of Evidence Assessment

Application	Evidence Level	Key Findings	Recommendation
Diabetic Foot Ulcers	Level I (High)	Multiple RCTs demonstrate superior healing rates (70-97%) and faster closure times	Strong recommendation for use in non-healing DFUs after 4 weeks of standard care
Venous Leg Ulcers	Level II (Moderate)	RCTs show 60% closure with adjunctive use; particularly effective for ulcers >12 weeks duration	Moderate recommendation as adjunct to compression therapy for refractory VLUs
Pressure Ulcers	Level II-III (Limited)	Small RCTs and cohort studies show promising results; larger studies needed	Conditional recommendation for Stage III-IV pressure ulcers after standard care failure
Surgical Wounds	Level III (Limited)	Case series show accelerated healing in complex surgical defects; limited comparative data	Consider for complex surgical wounds with exposed structures

Evidence Level Definitions:

Level I: Multiple high-quality RCTs with consistent findings

Level II: Single high-quality RCT or multiple lower-quality RCTs

Level III: Non-randomized controlled trials, cohort studies, or case series

Approximately 6.5 million people in the United States, or about 1 in 38 adults, are affected by chronic wounds each year.

* Chronic Wound Management: From Gauze to Homologous Cellular Matrix

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