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2021 FDA Update on BIOLOGICS

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Update on use of BIOLOGICS in Orthopedic conditions including joint injections for arthritis. Many remain ILLEGAL.
2021 FDA Update on BIOLOGICS

2021 FDA Update on BIOLOGICS

2021 FDA Update on BIOLOGICS

ken sherman2021-04-03T01:18:01+00:000 Comments

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Recent Posts

Cowboy Medicine August 29, 2023
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Update on Stem Cells and Biologics in Orthopedics and the use for musculoskeletal related pain/disorders (muscles, ligaments, tendons, joints) April 27, 2022
Dr. Bailie nominated for the prestigious Better Business Bureau (BBB) TORCH Award for Ethics for a healthcare business April 27, 2022
Update on use of BIOLOGICS in Orthopedic conditions including joint injections for arthritis. Many remain ILLEGAL. April 3, 2021
Dr. Bailie Featured in Orthopedics Today Discussing “in-office” Arthroscopy December 17, 2020

David S. Bailie, MD. | AzISKS Arizona Institute for Sports, Knees, and Shoulders. 2017

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Research Studies

2021 FDA Update on BIOLOGICS

Stem Cell _scams_ presented at AAOS

Jay – Initial Clinical Experience with the Use of Human Amniotic Membrane Tissue During Repair of Posterior Tibial and Achilles Tendons (MiMedx OEM – AFcell)

Jay – Initial Clinical Experience with the Use of Human Amniotic Membrane Tissue During Repair of Posterior Tibial and Achilles Tendons (MiMedx OEM – AFcell) (1)

IWJ Mrugala A – Amniotic membrane is a potential regenerative option for chronic non-healing wounds a report of five cases receiving dehydrated human amnion-chorion me

Intra-articular injection of micronized dehydrated human amnion-chorion membrane attenuates osteoarthritis development

Gellhorn Article

Gellhorn Article Corrected Proof

Dulemba – Evaluation of Dehydrated Human Amnion_Chorion Membrane as an Adhesion Barrier in Women Undergoing Robotic Laparoscopy

dHACM allograft promotes cardiac repair following myocardial infarction

Dehydrated human amnion-chorion membrane regulates stem cell activity in vitro

Dehydrated human amnion-chorion membrane for the treatment of full-thickness plantar burn in a diabetic patient_ a case report

Dehydrated human amnion-chorion membrane allografts in patients with chronic diabetic foot ulcers_ A long-term follow-up study

Dehydrated Human Amnion-Chorion Membrane (dHACM) Allografts as a Therapy for Orthopedic Tissue Repair

Dehydrated amniotic membrane allografts for the treatment of chronic wounds_ a case series

Cytokines in single layer amnion allografts compared to multilayer amnion-chorion allografts for wound healing Cell Recruitment by Amnion Chorion Grafts Promotes Neovascularization

Biological properties of dehydrated human amnion-chorion composite graft_ implications for chronic wound healing

Aufiero Journal of Pain & Relief – Treatment of Medial and Lateral Elbow Tendinosis with an Injectable_Amniotic Membrane Allograft – A Retrospective Case Series

Aufiero Journal of Pain & Relief – Treatment of Medial and Lateral Elbow Tendinosis with an Injectable_Amniotic Membrane Allograft – A Retrospective Case Series

Angiogenic properties of dehydrated human amnion_chorion allografts_ therapeutic potential for soft tissue repair and regeneration

An Evaluation of Healing Metrics Associated With Commonly Used Advanced Wound Care Products For the Treatment of Chronic Diabetic Foot Ulcers

An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs

An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs (1)

A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion_chorion membrane allograft in the management of diabetic f

A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers

A Multi-center Randomized Controlled Clinical Trial Evaluating the Use of Dehydrated Human Amnion-Chorion Membrane Allografts and Multi-layer Compression Therapy vs. M

2.11 – S9 – Placental Cells and Tissues_ The Transformative Rise in Advanced Wound Care

Zelen IWJ RCT Dec 2015 – Treatment of chronic diabetic lower extremity ulcers with advanced therapies_ a prospective, randomised, controlled, multi-centre comparative

Zelen IWJ – A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dHACM allograft, bioengineered skin substitute or stan

Wisco Article – Mohs – Case series_ The use of a dHACM allograft to enhance healing in the repair of lower eyelid defects after Mohs micrographic surgery

Willett, Guldberg, et al. – Intra-articular injection of micronized dehydrated human amnion_chorion membrane attenuates osteoarthritis development

Utilizing Dehydrated Human Amnion_Chorion Membrane Allograft in Transcanal Tympanoplasty

Using Amniotic Membrane Allografts in the Treatment of Neuropathic Foot Ulcers

Use of dehydrated human amniotic membrane allografts to promote healing in patients with refractory non healing wounds

Type I and II Diabetic Adipose-Derived Stem Cells Respond In Vitro to Dehydrated Human Amnion_ Chorion Membrane Allograft Treatment by Increasing Proliferation, Migrat

The Use of a dHACM Allograft in Patients Who Subsequently Undergo Reexploration after Posterior Lumbar Instrumentation

Tenenhaus JWC – dHACM for the treatment of severe skin and tissue loss in a preterm infant – a case report

Serena – Dehydrated human amnion_chorion membrane treatment of venous leg ulcers_ correlation between 4-week and 24-week outcomes

Scientific and Clinical support for the use of dehydrated amniotic membrane in wound management

SB300.003 A Primer on Amniotic Membrane Regenerative Healing

S19 Clinical_Experience__Using_dHACM Reilly Hickey Glat Lineaweaver Goverman

S14 Current_Techniques_for_Burn_Reconstruction Glat Davenport

S11 The_Use_of_Dehydrated_Human_Amnion_Chorion Tenenhaus

S9 Contemporary_Methods_Allowing_for_Safe_ Herndon Branski

S2 History_and_Advancement_of_Burn_Treatments Liu Zhang Lineaweaver

S1 The_Evolution_of_Burn_Injury_Management Glat

Prospective, Randomized, Blinded, Comparative Study of Injectable Micronized Dehydrated Amniotic-Chorionic Membrane Allograft for Plantar Fasciitis—A Feasibility Study

Properties of dehydrated human amnion-chorion composite grafts_ Implications for wound repair and soft tissue regeneration

Price J Robotic Surgery – Robotic repair of a vesicovaginal fistula in an irradiated field using a dehydrated amniotic allograft as an interposition patch

Placental Cells and Tissues in Advanced Wound Care

Patel Prostatectomy Article Dehydrated Human Amnion-Chorion Membrane Allograft Nerve Wrap Around the Prostatic Neurovascular Bundle Accelerates Early Return to Contine

Park -Mohs – A Novel Purse-String Suture and Dehydrated Human Amnion_ Chorion Membrane Allograft Closure Technique for the Repair of Defects Following Mohs Micrographi

OWM Snyder dHACM as Adjunctive Therapy of Pyoderma Gangrenosum 2015

Levengood arthroscopicassisted-anterior-cruciate-ligament-reconstruction…

Lei et al WHS – Identiﬁcation of Extracellular Matrix Components and Biological Factors in Micronized Dehydrated Human Amnion_Chorion Membrane

Lau – Bone and Tendon Coverage via Dehydrated Human Amniotic_Chorionic Membrane and Split-Thickness Skin Grafting

JWC Penny H – Dehydrated human amnion-chorion tissue in difficult–to-heal DFUs a case series

Amniofix

2021 FDA Update on BIOLOGICS

AmnioFix Science and Clinical Monograph

AmnioFix Anterior Cruciate Ligament

AmnioFix ACL Reconstruction Case Example

AmnioFix Growth Factors