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AmnioFix (amniotic membrance) injections for plantar fasciitis

Discussion in 'Biomechanics, Sports and Foot orthoses' started by admin, Aug 8, 2012.

  1. admin

    admin Administrator Staff Member


    Members do not see these Ads. Sign Up.
    In the thread on clinical trials update, this was posted:
    AmnioFix is a
    One of the listed application is plantar fasciitis, but none of the reference articles are related to musculoskeletal problems.

    The same company is also behind the EpiFix for diabetic foot ulcers
     
  2. Admin2

    Admin2 Administrator Staff Member

  3. phil

    phil Active Member

    Anyone else think this is ridiculous? Injecting a product made from human amniotic membrane for a condition that has a predominantly biomechanical cause?

    Check out all the registered trademarks. Anyone else creeped out by the concept of research to assess the effectiveness of using human tissue to establish a market for the sale of this tissue? For bloody plantar fasciitis! I mean, corneal transplants and other organs, ok that makes sense. But amniotic membrane for heel pain? Crazy.
     
  4. markjohconley

    markjohconley Well-Known Member

  5. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Prospective, Randomized, Blinded, Comparative Study of Injectable Micronized Dehydrated Amniotic/Chorionic Membrane Allograft for Plantar Fasciitis--A Feasibility Study.
    Zelen CM, Poka A, Andrews J.
    Foot Ankle Int. 2013 Aug 14.
     
  6. admin

    admin Administrator Staff Member

    Press Release:
    MiMedx Plantar Fasciitis Study Published In The Foot & Ankle International Journal
     
  7. NewsBot

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    Articles:
    1
    Cryopreserved Human Amniotic Membrane Injection for Plantar Fasciitis
    A Randomized, Controlled, Double-Blind Pilot Study

    Andrew E. Hanselman, John E. Tidwell, Robert D. Santrock
    Foot & Ankle International September 23, 2014
     
  8. NewsBot

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    Articles:
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    News story on Podiatrist using Amniofix:
    This month is a good time to look down
     
  9. NewsBot

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    Articles:
    1
    Amniotic Tissues for the Treatment of Chronic
    Plantar Fasciosis and Achilles Tendinosis

    Bruce Werber
    Journal of Sports Medicine; Volume 2015, Article ID 219896, 6 pages
     
  10. NewsBot

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    Articles:
    1
    A Prospective, Randomized, Blinded, Comparative Study of Injectable Micronized Dehydrated Amnion/Chorion Membrane Allograft in the Treatment of Recalcitrant Plantar Fasciitis
    Charles Zelen, Attila Poka, James Andrews
    Source
    Conclusion:
     
  11. NewsBot

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    Articles:
    1
    Plantar Fasciitis Treatment With Particulated Human Amniotic Memebrane
    David N. Garras, MD, Ryan T. Scott, DPM
    Foot & Ankle Orthopaedics September 2016 – December 2016 vol. 1 no. 1
     
  12. NewsBot

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    Articles:
    1
    This clinical trial was just registered:
    ReNu™ vs. Corticosteroids for the Treatment of Plantar Fasciitis
    ReNu is amniotic membrane and amniotic fluid cells.
     
  13. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    News Release
    MiMedx Reports Exceptional Results in Phase 2B Clinical Trial on the Use of AmnioFix® Injectable in the Treatment of Plantar Fasciitis
    MARIETTA, Ga., Aug. 2, 2017 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that it has closed enrollment in the Company's Plantar Fasciitis Investigational New Drug (IND) Phase 2B trial in accordance with an amendment filed with the Food and Drug Administration (FDA).

    Based on exceptional interim results, in late June, MiMedx submitted a summary results amendment along with a formal request to the FDA for closure and unblinding of its Plantar Fasciitis Phase 2B trial. The FDA has not requested any changes to the Company's amendment. It is important to note that the FDA had previously agreed to reduce the overall follow-up duration for the Phase 2B study from 24 months to 12 months and has now accepted a further reduction in the overall follow-up duration for the Phase 3 trial to 6 months, which underlines that the product is safe.

    The IND Phase 2B trial was a prospective, single-blinded, randomized, controlled trial of micronized dehydrated human amnion/chorion membrane (dhacm) injection as compared to a 0.9% Sodium Chloride USP placebo injection in the treatment of Plantar Fasciitis. In all, 14 study sites across the U.S. participated and 147 study subjects were randomized.

    IND Phase 2B Study Interim (Efficacy) Top Line Results

    The results from the two-sample t-test on paired differences indicated that the difference in the two groups was considered statistically significant at 3 months with a p-value equal to 0.0001 and at six months with a p-value of 0.0005. Analysis of the groups from the baseline visit through the six-month visit utilizing a linear mixed model indicated a statistically significant difference in VAS scores trending over time with a p-value of 0.0001. The IND Phase 2B study also included a blood collection cohort of at least 40 subjects for the testing of safety. At the time of the summary report, all patients from the blood collection cohort had reached the follow-up time point of 12 months, thereby making the immune compatibility testing complete. No immune response attributable to the treatment with AmnioFix was reported.

    Parker H. "Pete" Petit, Chairman and CEO, stated, "We believe this study will be a landmark one in demonstrating the impact of our dhacm micronized allografts in the treatment of a common orthopedic complaint, Plantar Fasciitis. The clinical results are extremely impressive and indicate very high statistical significance in the efficacy of micronized AmnioFix. We are looking forward to the publication of the study paper, and we expect it to be accomplished by one of the leading peer-reviewed journals."

    Bill Taylor, President and COO, said, "Plantar Fasciitis is a degenerative syndrome of the plantar fascia. The condition may be caused by repeated trauma or overuse creating micro-tears in the plantar fascia. Plantar Fasciitis is one of the most common orthopedic complaints relating to the foot, affecting approximately 9% of the U.S. population with approximately one million people per year seeking medical treatment.* We believe 60% of these patients could be potential candidates to receive an AmnioFix injection, which we estimate represents approximately a $450 million annual market opportunity for the Company.

    Taylor continued, "Many different companies are supplying physicians with potential solutions for Plantar Fasciitis with little therapeutic benefit, such as PRP, steroid injections, and dry needling. AmnioFix Injectable delivers a unique combination of benefits that other therapeutic agents cannot deliver to date for pain reduction and improvement in foot function with a simple-to-use micronized form for quick preparation with a saline injection."

    Conference Call
    MiMedx previously announced that it will host a live broadcast on Monday, August 7, 2017 at 2:00 p.m. eastern time. Additional information regarding this study and its interim results will also be included in that broadcast. A listen-only simulcast of the MiMedx conference call will be available online at the Company's website at www.mimedx.com. A 30-day online replay will be available approximately one hour following the conclusion of the live broadcast. The replay can also be found on the Company's website at www.mimedx.com.

    About MiMedx
    MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 900,000 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.

    *Reference: Riddle DL, Schappert SM, Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors, Foot Ankle Int. May 2004;25(5):303-10) and Millennium Report 2013

    Important Cautionary Statement
    This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. These statements also may be identified by words such as "believe," "except," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.
     
  14. NewsBot

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    Articles:
    1
    Particulate Umbilical Cord/Amniotic Membrane for the Treatment of Plantar Fasciitis
    David Garras MD, Ryan Scott, DPM
    Foot & Ankle Orthopaedics; September 18, 2017
     
  15. NewsBot

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    Articles:
    1
    Particulate Umbilical Cord/Amniotic Membrane for the Treatment of Plantar Fasciitis
    David Garras MD, Ryan Scott, DPM
    Foot & Ankle Orthopaedics September 18, 2017
     
  16. NewsBot

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    Articles:
    1
    News Release
    MiMedx Announces First Patients Have Been Enrolled In The Phase 3 Clinical Trial Of AmnioFix® Injectable In Patients With Recalcitrant Plantar Fasciitis Pain
    MARIETTA, Ga., Jan. 16, 2018 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, today announced the first patients have been randomized and enrolled in the pivotal Phase 3 Investigational New Drug (IND) clinical trial to assess the safety and efficacy of AmnioFix® Injectable in patients with recalcitrant plantar fasciitis pain.

    Top-line results from this study are expected in the second half of 2019. Following the conclusion of this trial, MiMedx intends to file a Biologic License Application (BLA) with the U.S. Food and Drug Administration for AmnioFix® Injectable to treat moderate to severe plantar fasciitis pain that has failed conservative treatment for at least 30 days. The Company projects the filing of the BLA related to plantar fasciitis will be in 2020.

    Plantar fasciitis is the most common cause of chronic heel pain in adults, making up 11–15% of the foot symptoms requiring professional care among adults, according to studies published in the Journal of Research in Medical Sciences. It is estimated that 1 in 10 people will develop PF during their lifetime. Plantar Fasciitis is one of the most common orthopedic complaints relating to the foot, affecting approximately 9% of the U.S. population with approximately one million people per year seeking medical treatment. The Company believes 60% of these patients could be potential candidates to receive an AmnioFix injection, which MiMedx estimates represents approximately a $450 million annual market opportunity for the Company.

    This Phase 3, prospective, double blinded, randomized controlled trial will enroll approximately 164 patients at 15 centers. Patients will be randomized 1:1 into two treatment groups; a single injection of saline (placebo control) or a single injection of 40mg of AmnioFix Injectable. The primary efficacy endpoint is the change in Visual Analog Scale (VAS) score between baseline and day 90, expressed as the difference in means between the two groups. The primary safety endpoint is the incidence of adverse events, serious adverse events, and unanticipated adverse events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-controlled group.

    Parker H. "Pete" Petit, Chairman and CEO, said, "I am pleased to announce that we have commenced enrolling the first Phase 3 patients in this significant study. For a long time, physicians treating musculoskeletal degeneration pain have highlighted the need for a new safe and durable first-line therapy, especially an injectable product. We believe AmnioFix Injectable meets this need and will quickly become the physician's product of choice for the vast majority of their patients."

    Bill Taylor, President and COO, added, "We expect this Phase 3 study will confirm the results seen in our Phase 2B study that showed AmnioFix Injectable has the potential to provide an effective, safe and durable relief from pain associated with chronic plantar fasciitis."

    About MiMedx
    MiMedx® is the 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 our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1 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.
     
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    Articles:
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  18. NewsBot

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    Articles:
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    Press Release:
    MiMedx Reports Positive Pain And Foot Function Results From Phase 2B Clinical Trial Of AmnioFix® Injectable In The Treatment Of Plantar Fasciitis
    Patients Experienced Clinically Meaningful Reduction in Pain
    AmnioFix Injectable Achieves Primary and Secondary Efficacy Endpoints
    Statistically Significant Difference in Pain and Function Compared to Placebo

    MARIETTA, Ga., March 26, 2018 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced positive pain and foot function results from its Phase 2B clinical trial of AmnioFix® Injectable in the treatment of Plantar Fasciitis.

    The Phase 2B IND clinical trial evaluating the use of AmnioFix Injectable for the treatment of Plantar Fasciitis demonstrated a clinically and statistically significant difference compared to patients in the Control Group in their reduction in the visual analog scale (VAS) score for pain (p<0.0001) and Foot Function Index-Revised (FFI-R) scores (p=0.0004) at 3 months compared to baseline. Additionally, the safety of the product was demonstrated by the absence of serious, unanticipated, product-related adverse events and the relative absence of an elicited immune response post-injection demonstrated by the Treatment Group.

    Plantar Fasciitis is the most common cause of chronic heel pain in adults, comprising 11–15% of the foot symptoms requiring professional care among adults, according to studies published in theJournal of Research in Medical Sciences. It is estimated that 1 in 10 people will develop Plantar Fasciitis during their lifetime, with approximately one million people per year seeking medical treatment. The Company believes 60% of these patients could be potential candidates to receive AmnioFix Injectable, which MiMedx estimates represents a $450 million annual market opportunity for the Company.

    "As we noted in January 2018 when we initiated our Phase 3 trial to treat Plantar Fasciitis, we believe AmnioFix Injectable can become a new first-line therapy for the treatment of musculoskeletal degeneration pain," said Parker H. "Pete" Petit, Chairman and Chief Executive Officer. "We believe that our product will meet this need and quickly become a physician's product of choice for patients."

    "These Phase 2B results clearly show that AmnioFix Injectable has the potential to provide safe, effective, and durable relief from pain associated with chronic Plantar Fasciitis," added Bill Taylor, President and COO. "We expect our Phase 3 study initiated in January 2018 to confirm these results as we move toward filing a Biologics License Application (BLA) in the second half of 2020 based on our current projections."

    Clinical Study Design
    The Phase 2B prospective, single-blinded, randomized, controlled trial studied a single injection of 40 mg of AmnioFix Injectable (micronized Dehydrated Human Amnion/Chorion Membrane (dHACM) Injection) as compared to a single injection of saline (placebo control) in the treatment of Plantar Fasciitis. The trial enrolled and treated 145 patients at 14 study sites.

    The primary efficacy endpoint was the change in VAS score for pain for subjects between baseline and 3 months expressed as the difference in the mean scores between the AmnioFix Injectable Treatment Group versus placebo-treated Control Group. The principal secondary efficacy endpoint was the change in FFI-R score for patients between baseline and 3 months expressed as the difference in mean scores between the AmnioFix Injectable Group versus the Control Group.

    Summary of Top-line AmnioFix Injectable Phase 2B Results
    The Phase 2B IND clinical trial evaluating the use of AmnioFix Injectable for the treatment of Plantar Fasciitis demonstrated a clinically and statistically significant difference compared to patients in the Control Group in their reduction in VAS score for pain and FFI-R scores at 3 months compared to baseline. Additionally, the safety of the product has been demonstrated by the absence of serious, unanticipated, product-related adverse events and the relative absence of an elicited immune response post-injection demonstrated by the Test Group.

    At three months, the Treatment Group (n=73) experienced a mean reduction of 54.1 points in their VAS score for pain compared to baseline. The Control Group (n=72) experienced a mean reduction of 31.9 points in their VAS score for pain at three months compared to baseline, a difference of 22.2 points between the two treatment groups (p<0.0001).

    At three months, the Treatment Group experienced a mean reduction of 36 points in FFI-R score compared to baseline. The Control Group experienced a mean reduction of 22 points in FFI-R at three months compared to baseline, a difference of 14 points between the two treatment groups (p=0.0004).

    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 give physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1 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.
     
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    Randomized Controlled Trial of Micronized Dehydrated Human Amnion/Chorion Membrane (dHACM) Injection Compared to Placebo for the Treatment of Plantar Fasciitis
    Shawn Cazzell, DPM, Jordan Stewart, DPM, Patrick S. Agnew, DPM, ...
    Foot & Ankle International July 30, 2018
     
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    Media Release:
    MiMedx Concludes Enrollment For Phase 3 Plantar Fasciitis Trial
    September 17, 2020 at 10:59 AM EDT
    Research in Plantar Fasciitis Advances Understanding of Amniotic Tissue as Potential Treatment for Chronic Musculoskeletal Pain and Function Disorders

    MARIETTA, Ga., Sept. 17, 2020 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (OTC PINK: MDXG) (“MiMedx” or “the Company”), an industry leader in advanced wound care and an emerging therapeutic biologics company, today announced the conclusion of enrollment for a Phase 3 study of plantar fasciitis, an inflammation of the fibrous tissue along the bottom of the foot that results in intense pain. This key clinical trial explores how placental science may address and treat musculoskeletal pain and function disorders. The study has met its timelines.

    "Plantar fasciitis is an all-too-common, debilitating and painful foot condition that challenges both patients and clinicians. Several months to years of treatment may be required with conservative therapies before symptoms subside, and I believe plantar fasciitis represents a significant unmet patient need," said Stuart Miller, M.D., Principal Investigator, Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, and Assistant Professor, Department of Orthopaedic Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland. “This is a landmark study that will help us advance the science and elevate the standard of care for millions of patients; I look forward to analyzing and publishing the data regarding treatment efficacy for this musculoskeletal condition. Our progress to date is all the more gratifying given the dampening effect of the pandemic on patient enrollment. This study is designed to provide statistically significant evidence of efficacy for this biologic treatment to reduce pain and improve function.”

    More than two million people are treated for plantar fasciitis inflammation in the United States annually. In 10% of patients treated with traditional measures, the condition progresses to chronic plantar fasciitis-related pain – recovery from which is lengthy and recurrence of which is very common, with an estimated $284 million annual national economic burden. The current treatment algorithm aims to maintain arch shape, modify foot loading and/or improve shock absorbency of the heel through night splints and orthotics. While they may assist in reducing pain associated with plantar fasciitis, these treatments do not address the root cause of the condition, which is thought to be both degenerative and inflammatory.

    Timothy R. Wright, MiMedx Chief Executive Officer, commented, “Given the variability of efficacy, cost, and potential side effects of available plantar fasciitis treatment options, additional evidence-based alternatives are needed urgently. As a pioneer in the development of placental tissue technology, following through on clinical research is part of our mission to improve patient outcomes. Using our placental science platform to address the unmet need posed by plantar fasciitis is just one of the critical ways that we are exploring its application to improve people’s lives. We look forward to sharing the results of this trial in 2021.”

    About the MiMedx Plantar Fasciitis Trial
    This study is a Phase 3, prospective, double-blinded, randomized controlled trial of the micronized dehydrated Human Amnion Chorion Membrane (dHACM) injection as compared to saline placebo injection in the treatment of plantar fasciitis. The trial enrolled 276 patients between the ages of 21 and 79 years, with an investigator-confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months. Patients were required to have a Visual Analog Scale (VAS) Pain scale of ≥ 45 mm at randomization and be receiving conservative treatment for ≥ 1 month (30 days), including any of the following modalities: Rest, Ice, Compression, Elevation (RICE); stretching exercises; NSAIDs or orthotics. The primary endpoints are change in VAS for Pain at 90 Days and incidence of related adverse events at 180 days, serious adverse events and unanticipated events during the first 12 months post-injection. Secondary endpoints include self-reported responses to the Foot Function Index – Revised (FFI-R) at 90 days.
     
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