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- Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions.Stem Cells Transl Med. 2018; 7: 676-685
- Stem cell tourism and the power of hope.Am J Bioeth. 2010; 10: 16-23
- SCIENTIFIC COMMUNITY. Confronting stem cell hype.Science. 2016; 352: 776-777
- Highlights from the American Medical Society for Sports Medicine position statement on responsible use of regenerative medicine and orthobiologics in sports medicine.Br J Sports Med. 2022; 56: 121-122
- Global Distribution of Businesses Marketing Stem Cell-Based Interventions.Cell Stem Cell. 2016; 19: 158-162
- Could cancer and infection be adverse effects of mesenchymal stromal cell therapy?.World J Stem Cells. 2015; 7: 408-417
- Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry.Cell Stem Cell. 2016; 19: 154-157
Research USDoHaHSFaDACfBEa. Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide. 2007.
Title 21 Code of Federal Regulations Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products.
- Establishment registration and listing for manufacturers of human cellular and tissue-based products--FDA. Proposed rule.Fed Regist. 1998; 63: 26744-26755
- Direct-to-consumer stem cell marketing and regulatory responses.Stem Cells Transl Med. 2013; 2: 638-640
- Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.https://www.fda.gov/media/109176/download#:∼:text=4%20Examples%20of%20HCT%2FPs,semen%20or%20other%20reproductive%20tissueDate accessed: March 10, 2022
- Food and Drug Administration's Position on Commonly Injected Biologic Materials in Orthopaedic Surgery.Am J Sports Med. 2021; 49: 3414-3421
- Ortho-Biologics for Osteoarthritis.Clin Sports Med. 2019; 38: 123-141
- Platelet-rich plasma (PRP): what is PRP and what is not PRP?.Implant Dent. 2001; 10: 225-228
- US definitions, current use, and FDA stance on use of platelet-rich plasma in sports medicine.J Knee Surg. 2015; 28: 29-34
- Stem Cell Treatment for Knee Articular Cartilage Defects and Osteoarthritis.Curr Rev Musculoskelet Med. 2020; 13: 20-27
- The Economics and Regulation of PRP in the Evolving Field of Orthopedic Biologics.Curr Rev Musculoskelet Med. 2018; 11: 558-565
- Review of the processes for FDA oversight of drugs, medical devices, and combination products.J Manag Care Pharm. 2011; 17: 40-50
- Bone Marrow Aspirate Concentrate: Its Uses in Osteoarthritis.Int J Mol Sci. 2020; 21: 3224
- Clinical use of bone marrow, bone marrow concentrate, and expanded bone marrow mesenchymal stem cells in cartilage disease.Stem Cells Dev. 2013; 22: 181-192
- Microfragmented Adipose Tissue Injection (MFAT) May Be a Solution to the Rationing of Total Knee Replacement: A Prospective, Gender-Bias Mitigated, Reproducible Analysis at Two Years.Stem Cells Int. 2021; 2021: 9921015
- Patient-Centered Outcomes of Microfragmented Adipose Tissue Treatments of Knee Osteoarthritis: An Observational, Intention-to-Treat Study at Twelve Months.Stem Cells Int. 2020; 2020: 8881405
- Cartilage regeneration by chondrogenic induced adult stem cells in osteoarthritic sheep model.PLoS One. 2014; 9: e98770
- Production of canine mesenchymal stem cells from adipose tissue and their application in dogs with chronic osteoarthritis of the humeroradial joints.Cell Biol Int. 2012; 36: 189-194
- Stem cells: their source, potency and use in regenerative therapies with focus on adipose-derived stem cells - a review.Biotechnol Adv. 2018; 36: 1111-1126
- Effect of tissue-harvesting site on yield of stem cells derived from adipose tissue: implications for cell-based therapies.Cell Tissue Res. 2008; 332: 415-426
- Adipose tissue-derived mesenchymal stem cell yield and growth characteristics are affected by the tissue-harvesting procedure.Cytotherapy. 2006; 8: 166-177
- Regenerative Features of Adipose Tissue for Osteoarthritis Treatment in a Rabbit Model: Enzymatic Digestion Versus Mechanical Disruption.Int J Mol Sci. 2019; 20: 2636
- Microfragmented adipose injections in the treatment of knee osteoarthritis.J Clin Orthop Trauma. 2019; 10: 46-48
FDA Office of Communication O, (OCOD) aD. Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception. Accessed May 2022.
- Cytokine levels in midtrimester amniotic fluid in normal pregnancy and in the prediction of pre-eclampsia.Scand J Immunol. 2001; 53: 310-314
- Differences in amniotic fluid and maternal serum cytokine levels in early midtrimester women without evidence of infection.Cytokine. 2008; 44: 78-84
- Growth factors and wound healing: biochemical properties of growth factors and their receptors.Am J Surg. 1993; 165: 728-737
- [Reference ranges of matrix metalloproteinase-1, -2, -9 and tissue inhibitor of matrix metalloproteinases-1 concentrations in amniotic fluid in physiological pregnancy].Biomed Khim. 2016; 62: 96-98
- Proteoglycans and hyaluronan in human fetal membranes.Am J Obstet Gynecol. 2001; 184: 679-685
- Glycosaminoglycan composition of human amniotic fluid.Biochim Biophys Acta. 1974; 354: 264-274
- Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells With Bone Marrow Comparison.Am J Sports Med. 2019; 47: 1230-1235
- Ethical issues in embryonic stem cell research.JAMA. 2001; 285: 1439-1440
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use (2020).
- FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products.(Available at:)https://www.fda.gov/news-events/press-announcements/fda-extends-enforcement-discretion-policy-certain-regenerative-medicine-products(Accessed April 4, 2022)
- American Medical Society for Sports Medicine Position Statement: Principles for the Responsible Use of Regenerative Medicine in Sports Medicine.Clin J Sport Med. 2021; 31: 530-541