NorLeu3-Angiotensin (1-7) [DSC127] as a Therapy for the Healing of Diabetic Foot Ulcers

NewsBot · Jun 3, 2015

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NorLeu3-Angiotensin (1-7) [DSC127] as a Therapy for the Healing of Diabetic Foot Ulcers.
Rodgers KE, Bolton LL, Verco S, diZerega GS
Adv Wound Care (New Rochelle). 2015 Jun 1;4(6):339-345.

Significance: Diabetes is a disorder that is well known to delay wound repair resulting in the formation of colonized chronic wounds. Over their lifetime, diabetic patients have a 25% incidence of foot ulcers (DFUs), which contribute to increased risk of morbidity, including osteomyelitis and amputations, and increased burden to the healthcare system.

Recent Advances: The only active product approved for the treatment of diabetic ulcers, Regranex®, is not widely used due to minimal proven efficacy and recent warnings added to the Instructions for Use. A novel topical agent that accelerates healing and increases the proportion of fully healed DFUs, DSC127 [aclerastide; active ingredient, NorLeu3-angiotensin (1-7) (NorLeu3-A(1-7))], is recruiting patients in Phase III clinical trials (NCT01830348 and NCT01849965). NorLeu3-A(1-7) is an analog of the naturally occurring peptide, angiotensin 1-7. The mechanisms of action include induction of progenitor proliferation, accelerated vascularization, collagen deposition, and re-epithelialization.

Critical Issues: Current modalities for the treatment of DFUs include strict offloading, bandaging, debridement and, on a limited basis, application of Regranex. Novel potent therapies are needed to combat this significant burden to the diabetic patient and the healthcare system. Future Direction: Preclinical and clinical research shows that DSC127 is highly effective in the closure of diabetic wounds and is superior to Regranex in animal studies. Clinical development of DSC127 as a topical agent for the healing of DFU is underway. Further investigation into the mechanisms by which this product accelerates healing is warranted.
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Admin2 · Jun 3, 2015

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NewsBot · Jun 26, 2015

Press Release:
Derma Sciences Announces Publication in Advances in Wound Care
Review of aclerastide clinical development program for the treatment of diabetic foot ulcers underscores potential as an effective pharmaceutical within a multi-billion dollar market

PRINCETON, N.J., Jun 25, 2015 (BUSINESS WIRE) -- Derma Sciences, Inc. DSCI, -2.90% a tissue regeneration company focused on advanced wound and burn care, announces the publication of a review of the current clinical development program for aclerastide (DSC127), a patented peptide analog of angiotensin, as a potential treatment for the closure of diabetic foot ulcers (DFUs) in an article titled, “NorLeu3-Angiotensin (1-7) [DSC127] as a Therapy for the Healing of Diabetic Foot Ulcers,” in the peer-reviewed journal, Advances in Wound Care. The full article can be accessed here or on the Company’s website at www.dermasciences.com.

Aclerastide, also known as NorLeu3-A(1-7), is an analog of the active member of the RAS, A(1-7). The peptide accelerates and normalizes the healing/closure of dermal injuries in multiple animal models. In Phase I and II human clinical studies, aclerastide increased the incidence of full closure of DFUs.

The review cited the article by Balingit et al Wound Rep Reg 2012 stating, “The efficacy of this product was seen as early as 4 weeks with a reduction in wound volume. This observation is consistent with that observed in preclinical studies where normal granulation tissue was rapidly deposited. By week 12, there was an absolute increase in full wound closure in the Phase II trial of 27%. The benefit continued over the durability phase of the trial where at 24 weeks after initiation of treatment (20 weeks since the last exposure), the absolute increase in complete wound closure was 27–33% (52% of PP [per protocol] placebo subjects or 85% of 0.03% DSC127 PP subjects healed; 46% of ITT [intent-to-treat] placebo subjects or 73% of 0.03% DSC127 ITT subjects healed) even in the face of less rigorous clinical oversight and off-loading requirements after the first 12 weeks of study participation.”

Lead study author, Kathleen E. Rodgers, Ph.D., School of Pharmacy, University of Southern California, Los Angeles, noted that, “DSC127 and its active ingredient, NorLeu3-A(1-7), are potent stimulators of tissue repair and possibly regeneration leading to increased proportions of complete full-thickness wound healing. To date, DSC127 has been shown to be well tolerated in both preclinical and clinical studies.”

“We are very pleased to have these important data from studies with aclerastide summarized in this peer-reviewed journal article. We are encouraged by the fact that the journal editors considered this information important and timely, such that they invited the lead author to write this review, particularly since aclerastide is the only drug in late stage development with the goal of demonstrating an increased incidence of closure of DFUs. We look forward to the publication of additional articles on the clinical merits of this unique mechanism of action as we deploy our rigorous publication strategy,” noted John Caminis, M.D., chief medical officer of Derma Sciences.

“We are beyond the half way mark with the enrollment into our Phase III study of aclerastide for the accelerated healing of diabetic foot ulcers and expect that the encouraging data presented in this journal article will bring attention to this Phase III study and could enhance enrollment. We very excited about aclerastide’s potential as a new therapeutic option for the up to 1.5 million people in the U.S. suffering from diabetic foot ulcers. With no approved robust pharmaceutical solution for treating these chronic wounds that often lead to amputations, we believe this program offers tremendous opportunity in a multibillion-dollar market with significant unmet medical need,” commented Edward J. Quilty, Derma Sciences’ chairman and chief executive officer.

About Derma Sciences, Inc.

Derma Sciences is a tissue regeneration company focused on advanced wound and burn care. It offers a line of products with patented technologies to help better manage chronic and hard-to-heal wounds, many of which result from diabetes and poor vascular functioning. The Company sells AMNIOEXCEL® amniotic allograft membrane and AMNIOMATRIX® amniotic allograft suspension into the $500 million market for skin substitute products. Derma Sciences’ MEDIHONEY® product line is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown in clinical studies to be effective in a variety of indications. TCC-EZ® is a gold-standard total contact casting system for diabetic foot ulcers. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudate, and BIOGUARD® for barrier protection against microbes and other contaminants. Its pharmaceutical product in development, aclerastide (a patented peptide analog of angiotensin), is currently in Phase 3 and 3b clinical trials for the closure of diabetic foot ulcers. Aclerastide is also in preclinical development for the prevention and reduction of scarring after surgical incision and wound closure. Aclerastide is also part of a BARDA grant program for the mitigation and treatment of skin damage associated with exposure to ionizing radiation. The Company also offers a full product line of traditional dressings.
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NewsBot · Nov 12, 2015

Press release:
Derma Sciences Announces Results of Futility Analyses for Phase 3 Clinical Trials of Aclerastide in Diabetic Foot Ulcer Healing

Derma Sciences, Inc. (Nasdaq: DSCI), a tissue regeneration company focused on advanced wound and burn care, announces the termination of its Phase 3 clinical trials with aclerastide (DSC127) for diabetic foot ulcer healing. This action is based on futility determinations conducted by the Data Monitoring Committee (DMC) for the planned, pre-specified interim analyses regarding the primary efficacy endpoint of confirmed complete wound closure of the target ulcer within 12 weeks of the start of treatment. The decision to end the studies followed the recommendation by the DMC to stop enrollment in the studies. The DMC also reported that there were no safety concerns attributed to aclerastide.

“We have stopped further enrollment and initiated an orderly termination of the aclerastide trials and program, which we believe will be substantially complete by year end. We are also halting all development work with DSC127 in scar reduction and radiation dermatitis.”

“We are very disappointed with the findings of the analyses of the DMC, but are grateful for the support and commitment from the participating patients and the study investigators,” said Edward J. Quilty, chairman and chief executive officer of Derma Sciences. “We have stopped further enrollment and initiated an orderly termination of the aclerastide trials and program, which we believe will be substantially complete by year end. We are also halting all development work with DSC127 in scar reduction and radiation dermatitis.”

The development program termination eliminates a projected cash burn of approximately $5 million per quarter in 2016. As of September 30, 2015 Derma Sciences had $49.4 million of cash and cash equivalents and $12.0 million of long-term investments. The Company’s primary focus is to continue to grow its advanced wound care net sales and increase gross margins. The Derma Sciences Board of Directors and senior management are committed to a path of profitable growth and positive operating cash flow in 2016, including assessing all aspects of the Company’s operations and infrastructure that could enhance shareholder value.
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NewsBot · Mar 7, 2016

Press Release:
Findings from Multicenter Study Comparing Derma Sciences’ AMNIOEXCEL? Against Standard-of-Care for Treating Diabetic Foot Ulcers Published in WOUNDS, a Leading Peer-Reviewed Journal

Derma Sciences, Inc. (NasdaqSCI), a tissue regeneration company focused on advanced wound and burn care, announces that a peer-reviewed comparative clinical study of AMNIOEXCEL? Amniotic Allograft Membrane plus standard-of-care (SOC), compared with SOC alone, for the closure of hard-to-treat diabetic foot ulcers, has been published. The results are statistically significant and clinically meaningful, with the closure rate at six weeks in the AMNIOEXCEL? plus SOC treatment arm far exceeding the SOC alone treatment arm.

The study, “A Prospective, Randomized, Controlled, Multicenter Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcers,” was published in the peer-reviewed journal WOUNDS. The Early View electronic publication of the study is now available here and the publication is expected to follow in the March 2016 print issue of the journal.

The study analyzed data from 29 patients enrolled in a prospective, randomized, controlled, multicenter clinical trial and showed that AMNIOEXCEL? plus SOC is superior to SOC alone. The endpoint was the proportion of subjects with complete wound closure (defined as complete re-epithelialization without drainage or need for dressings), and patients were treated until the earlier of wound closure or six weeks. To ensure that only non-closing wounds were treated, all wounds were at least four weeks old and all prospective study subjects participated in a two-week run-in period of SOC. Only those patients whose wounds did not close by 30% or more during the two-week period were enrolled in the study.

Highlights of the study’s findings include:

35% of subjects in the intent-to-treat AMNIOEXCEL? plus SOC cohort achieved complete wound closure at or before week six, compared with 0% of subjects in the intent-to-treat SOC alone cohort – these results are statistically significant (p=0.017)
45.5% of subjects in the per-protocol AMNIOEXCEL? plus SOC cohort achieved complete wound closure at or before week six, compared with 0% of subjects in the per-protocol SOC alone cohort – these results are statistically significant (p=0.0083)
No treatment-related adverse events were reported in either cohort
The study was funded by Derma Sciences and the paper was authored by Robert J. Snyder, DPM; Kenneth Shimozaki, DPM; Arthur Tallis, DPM; Michael Kerzner, DPM; Alexander Reyzelman, DPM; Dimitrios Lintzeris, DO; Desmond Bell, DPM; Randi Rutan; and Barry Rosenblum, DPM.

This Level 1 published evidence supports the use of AMNIOEXCEL? for the treatment of non-closing diabetic foot ulcers.

Stephen T. Wills, Derma Sciences Executive Chairman and Interim Chief Executive Officer, said, “Most importantly, these results are great news for people suffering from chronic, hard-to-treat diabetic foot ulcers. In this well-designed and tightly administered study, patients treated with AMNIOEXCEL? along with standard of care had a far superior wound closure and a more rapid rate of wound closure than those treated with standard of care alone. These results are statistically significant and clinically meaningful, which is very important to health plan decision-makers in reviewing new coverage decisions. This study will enhance our efforts to gain positive coverage decisions from the remaining three Medicare Administrative Contractors who currently do not have a policy on AMNIOEXCEL? and require robust, evidence-based studies for their local coverage determinations."

Barry J. Wolfenson, Group President of Advanced Wound Care, commented, “Given the large proportion of people with type 1 or type 2 diabetes who will ultimately develop a foot ulcer, and the high rate of amputation associated with diabetic foot ulcers along with the mortality associated with these amputations, we are thrilled to share these exceptional data with the doctors and nurses who care for these patients on a daily basis. This should give clinicians high confidence in AMNIOEXCEL? as a clinically safe and efficacious product, offering them a viable, cost-effective solution.”

About the Trial Design and Findings

All subjects enrolled in this study received SOC throughout the trial, including the two-week run-in period. SOC included debridement of necrotic/non-viable tissue, moist wound dressings, off-loading and infection surveillance and management. Patients with chronic, diabetes-related wounds between 1 cm2 and 25 cm2 in area, which failed to close more than 30% in area during the two-week SOC run-in period, were randomly assigned 1:1 to receive AMNIOEXCEL? + SOC or SOC alone. Subjects in both groups returned to the clinic every week for dressing changes, wound inspection, debridement and dressing application. In these weekly assessments, the wounds also were photographed and measured. The primary endpoint of the study, complete closure of the ulcer without drainage or need for dressings, was assessed each week.

Of the 49 patients screened for participation, 29 were randomized with 15 allocated to the AMNIOEXCEL? + SOC group and 14 allocated to the SOC alone group. All randomized subjects were included in the intent to treat (ITT) analysis and the 21 subjects (11 AMNIOEXCEL? + SOC and 10 SOC) who completed the six-week trial were included in the per-protocol (PP) analysis. Subjects in the AMNIOEXCEL? + SOC group demonstrated a significantly greater closure rate than the SOC alone subjects, with 35% closure at six weeks in the AMNIOEXCEL? +SOC group vs. 0.0% closure in the SOC group in the ITT population (p=0.017), and 45.5% closure at six weeks in the AMNIOEXCEL? +SOC group vs. 0.0% closure in the SOC group in the PP population (p=0.0083).

The study was implemented at eight U.S. clinical sites.

About AMNIOEXCEL? Membrane

AMNIOEXCEL? Amniotic Allograft Membrane is a novel human placental-based tissue product. The membrane forms a protective covering over the wound while providing the key components found in human amnion including an intact ECM (extracellular matrix), cytokines and other growth factors. It easily integrates into the wound and helps provide the optimal environment to repair, reconstruct and replace wound tissue.

About Derma Sciences, Inc.

Derma Sciences is a tissue regeneration company focused on advanced wound and burn care. It offers a line of products with patented technologies to help better manage chronic and hard-to-heal wounds, many of which result from diabetes and poor vascular functioning. The Company sells AMNIOEXCEL? amniotic allograft membrane and AMNIOMATRIX? amniotic allograft suspension into the $500 million market for skin substitute products. TCC-EZ? is a gold-standard total contact casting system for diabetic foot ulcers. Derma Sciences’ MEDIHONEY? product line is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown in clinical studies to be effective in a variety of indications. Other novel products introduced into the $14 billion global wound care market include XTRASORB? for better management of wound exudate, and BIOGUARD? for barrier protection against microbes and other contaminants. The Company also offers a full product line of traditional dressings. For more information please visit www.dermasciences.com.
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NewsBot · Mar 16, 2016

A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer.
Snyder RJ et al
Wounds. 2016 Mar;28(3):70-77.

Delayed closure of foot ulcers is a primary factor leading to lower extremity amputation in patients with diabetes, creating great demand for products or therapies to accelerate the rate of wound closure in this population. This study (ClinicalTrials.gov Identifier: NCT02209051) was designed to evaluate dehydrated amniotic membrane allograft (DAMA) (AMNIOEXCEL, Derma Sciences Inc, Princeton, NJ) plus standard of care (SOC) compared to SOC alone for the closure of chronic diabetic foot ulcers (DFUs).
MATERIALS AND METHODS:
This prospective, open-label, randomized, parallel group trial was implemented at 8 clinical sites in the United States. Eligibility criteria included adults with type 1 or type 2 diabetes mellitus who have 1 or more ulcers with a Wagner classification of grade 1 or superficial 2 measuring between 1 cm2 and 25 cm2 in area, presenting for more than 1 month with no signs of infection/osteomyelitis; ABI > 0.7; HbA1c Less than 12%; and serum creatinine less than 3.0 mg/dL. Eligible subjects were randomized (1:1) to receive either SOC alone (n = 14) or DAMA+SOC (n = 15) until wound closure or 6 weeks, whichever occurred first. The endpoint was the proportion of subjects with complete wound closure (defined as complete reepithelialization without drainage or need for dressings).
RESULTS:
Thirty-five percent of subjects in the DAMA+SOC cohort achieved complete wound closure at or before week 6, compared with 0% of the SOC alone cohort (intent-to-treat population, P = 0.017). There was a more robust response noted in the per protocol population, with 45.5% of subjects in the DAMA+SOC cohort achieving complete wound closure, while 0% of SOC-alone subjects achieved complete closure (P = 0.0083). No treatment-related adverse events were reported.
CONCLUSION:
The results suggest DAMA is safe and effective in the management of DFUs, but additional research is needed.
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NewsBot · Mar 24, 2016

Press Release:
AMNIOX Highlights Study Showing More Than Eighty Seven Percent of Patients With Diabetic Foot Ulcers Achieve Healing When Treated with NEOX? Wound Allograft

-AMNIOX Medical, Inc., a TissueTech, Inc., company, announced the results of a retrospective clinical study of cryopreserved Umbilical Cord and Amniotic Membrane (UC/AM) tissue for chronic wound management, a review of the effectiveness of NEOX? Wound Allograft in treating patients with chronic diabetic foot ulcers. The findings were presented at Superbones Superwounds East 2016, where the study’s author, Allen Raphael, DPM, was among many top speakers on faculty at the conference.

“These findings are quite positive for the application of umbilical cord allograft for diabetic foot ulcers”
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The retrospective review was conducted on 29 patients presenting with 32 wounds. All wounds were debrided in an operating room or clinic before cryopreserved umbilical cord (NEOX? Wound Allograft) was placed directly over the wound, and secured in place with sutures.

Twenty-eight wounds demonstrated complete healing, to achieve a rate of 87.5 percent. Initial wound area was an average of 10.6 cm2, which is substantially larger than a typical diabetic foot ulcer. The average time to healing was 13.79 weeks, and the average number of applications of NEOX Wound Allograft was 1.68. Dr. Raphael concluded that cryopreserved umbilical cord is effective in promoting the rapid healing of chronic, diabetic foot ulcers, suggesting its usefulness as an advanced tissue treatment modality.

“These findings are quite positive for the application of umbilical cord allograft for diabetic foot ulcers,” Dr. Raphael said. “A close review of this data in comparison to other published studies also suggests more frequent applications most likely translates to faster healing, even considering larger initial wound size. High levels of the HC-HA/PTX3 protein complex in the umbilical cord appear to play a central role in successful healing in these cases. The tissue’s demonstrated effectiveness and ease-of-use make it a valuable option for these patients and the physicians overseeing their care.”

“The body of clinical evidence regarding umbilical cord tissue in regenerative healing is continuing to grow further,” said Tom Dugan, Chief Executive Officer of Amniox Medical. “If one compares this finding of an 87.5 percent healing rate with rates published for multiple alternatively processed amniotic membrane options, including for instance bioengineered skin substitutes and cryopreserved or dehydrated amniotic membrane, this is clearly a positive alternative, especially considering the larger-than-typical average wound size and fewer applications required for healing. Coupled with the storage flexibility Amniox tissues offer, and the ease of handling and application, the benefits are magnified.”

Amniox parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote regenerative healing. In utero, wound healing occurs rapidly and with minimal scar. This restorative ability is innate to these placental tissues and can be preserved and transplanted to adults. Heavy chain hyaluronic acid/pentraxin-3 (HC-HA/PTX3) is the key protein complex present in these tissues to orchestrate that regenerative healing process. Amniox Medical is the first provider of a human tissue allograft composed of both umbilical cord and amniotic membrane. Amniox utilizes its proprietary CRYOTEK process, a cryopreservation technology, to preserve the biological and structural integrity of these tissues more effectively than other available technologies. Since the company’s inception, clinicians have performed more than 200,000 human transplants of its products and published more than 300 peer-reviewed studies supporting its technology platform.
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NewsBot · Sep 24, 2018

A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers
William Tettelbach Shawn Cazzell Felix Sigal Joseph M. Caporusso Patrick S. Agnew Jason Hanft Cyaandi Dove
Int W J: 24 September 2018

The aim of this study was to determine the safety and effectiveness of dehydrated human umbilical cord allograft (EpiCord) compared with alginate wound dressings for the treatment of chronic, non‐healing diabetic foot ulcers (DFU). A multicentre, randomised, controlled, clinical trial was conducted at 11 centres in the United States. Individuals with a confirmed diagnosis of Type 1 or Type 2 diabetes presenting with a 1 to 15 cm2 ulcer located below the ankle that had been persisting for at least 30 days were eligible for the 14‐day study run‐in phase. After 14 days of weekly debridement, moist wound therapy, and off‐loading, those with ≤30% wound area reduction post‐debridement (n = 155) were randomised in a 2:1 ratio to receive a weekly application of EpiCord (n = 101) or standardised therapy with alginate wound dressing, non‐adherent silicone dressing, absorbent non‐adhesive hydropolymer secondary dressing, and gauze bandage roll (n = 54). All wounds continued to have appropriate off‐loading during the treatment phase of the study. Study visits were conducted for 12 weeks. At each weekly visit, the DFU was cleaned and debrided as necessary, with the wound photographed pre‐ and post‐debridement and measured before the application of treatment group‐specific dressings. A follow‐up visit was performed at week 16. The primary study end point was the percentage of complete closure of the study ulcer within 12 weeks, as assessed by Silhouette camera. Data for randomised subjects meeting study inclusion criteria were included in an intent‐to‐treat (ITT) analysis. Additional analysis was conducted on a group of subjects (n = 134) who completed the study per protocol (PP) (EpiCord, n = 86, alginate, n = 48) and for those subjects receiving adequate debridement (EpiCord, n = 67, alginate, n = 40). ITT analysis showed that DFUs treated with EpiCord were more likely to heal within 12 weeks than those receiving alginate dressings, 71 of 101 (70%) vs 26 of 54 (48%) for EpiCord and alginate dressings, respectively, P = 0.0089. Healing rates at 12 weeks for subjects treated PP were 70 of 86 (81%) for EpiCord‐treated and 26 of 48 (54%) for alginate‐treated DFUs, P = 0.0013. For those DFUs that received adequate debridement (n = 107, ITT population), 64 of 67 (96%) of the EpiCord‐treated ulcers healed completely within 12 weeks, compared with 26 of 40 (65%) of adequately debrided alginate‐treated ulcers, P < 0.0001. Seventy‐five subjects experienced at least one adverse event, with a total of 160 adverse events recorded. There were no adverse events related to either EpiCord or alginate dressings. These results demonstrate the safety and efficacy of EpiCord as a treatment for non‐healing DFUs.
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NewsBot · Sep 26, 2018

Press Release:
MiMedx Publishes Positive Results From Clinical Study Of Human Umbilical Cord For Diabetic Foot Ulcers
September 25, 2018 at 8:30 AM EDT

Study Published in International Wound Journal Reported Statistically Significant Evidence of Healing Compared to Standardized Therapy (ST)
- Intent-To-Treat (ITT) EpiCord®-Treated Patients = 70% vs ST 48%, p=0.0089
- Per-Protocol EpiCord-Treated Patients = 81% vs ST 54%, p=0.0013

MARIETTA, Ga., Sept. 25, 2018 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that a new clinical study has been published in the peer-reviewed International Wound Journal, which evaluated the safety and efficacy of using dehydrated human umbilical cord (dHUC - EpiCord) for chronic diabetic foot ulcers (DFUs).

The paper is entitled "A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers" and was co-authored by: William Tettelbach, MD; Shawn Cazzell, DPM; Felix Sigal, DPM; Joseph M. Caporusso, DPM; Patrick S. Agnew, DPM; Jason Hanft, DPM; and Cyaandi Dove, DPM. The published article in the International Wound Journal can be found at https://onlinelibrary.wiley.com/doi/full/10.1111/iwj.13001.

This multicenter randomized and controlled trial was conducted at 11 centers in the United States and was led by William Tettelbach, MD, principal investigator and former Executive System Medical Director of Wound Care and Hyperbaric Medicine Services for Intermountain Healthcare. Dr. Tettelbach later became Associate Chief Medical Officer for MiMedx, a position that postdated the completion of the study.

Clinical Study Design and Results
This is the first published clinical study of dHUC tissue. The objective of the study was to determine the safety and effectiveness of dHUC as compared to standardized therapy with alginate wound dressings for chronic, non-healing DFUs.

The primary efficacy endpoint was the incidence of complete wound closure over a 12-week period. Data from 155 patients were analyzed in the Intent-to-Treat (ITT) cohort. Patients were randomized in a 2:1 ratio to receive weekly application of dHUC (n=101) or standardized therapy with alginate dressings (n=54). A total of 134 patients completed the study Per-Protocol (Per-Protocol cohort).

ITT analysis includes patients even if they did not fully adhere to the protocol. In comparison, in a Per-Protocol analysis, only patients who completed the entire clinical trial according to the protocol are included in the final analysis.

In the current study on an ITT basis, 70% of patients who received weekly dHUC had complete healing by 12 weeks versus 48% of patients only receiving weekly standardized therapy (p=0.0089).

For patients completing the study Per-Protocol, 81% of those who received weekly dHUC achieved complete healing by 12 weeks. In comparison, 54% of patients had complete healing in 12 weeks after receiving weekly standardized therapy (p=0.0013).

About dHUC
dHUC is a thick membrane derived from umbilical cord, the structure that protects the arteries and vein that carry essential nourishment and oxygenated blood to and from mother and fetus. dHUC is a minimally manipulated, dehydrated, non-viable cellular umbilical cord allograft intended for homologous use that provides a protective environment for the healing process.

Umbilical cord consists of amniotic epithelium and Wharton's jelly containing an extracellular matrix composed of collagen, proteoglycans and hyaluronic acid. MiMedx processes dHUC using the PURION® Plus process, an approach that provides an easy-to-use allograft stored at ambient conditions.

MiMedx currently markets dHUC as a Human Cellular and Tissue-based Product (HCT/P) under Section 361 of Food and Drug Administration regulations under the brand names EpiCord® and AmnioCord®. MiMedx manufactures its products according to current Good Tissue Practices (cGTP) standards, pursuant to 21 CFR 1271, an FDA regulation. The Company is also in compliance with the AATB's (American Association of Tissue Banks) 14th standard, of which MiMedx is a fully accredited member in good standing.

About MiMedx
MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind the Company's mission to provide physicians products to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

NorLeu3-Angiotensin (1-7) [DSC127] as a Therapy for the Healing of Diabetic Foot Ulcers

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NorLeu3-Angiotensin (1-7) [DSC127] as a Therapy for the Healing of Diabetic Foot Ulcers

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