Biology:Orthobiologics

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Orthobiologics, also known as regenerative orthopedics, is a branch of regenerative medicine that utilizes products derived from biological sources, such as blood, fat, or bone marrow, naturally found in the human body to help injuries heal more quickly and efficiently. Ongoing clinical trials are investigating the applications of biologics in orthopedics.

Orthobiologics may be used in the treatment of musculoskeletal conditions, such as certain forms of arthritis, as well as injuries to tendons, ligaments, bones, muscles, spinal discs, meniscus of the knee, cartilage, or other musculoskeletal tissues. Biologics used in orthopedics can be derived from a patient's own body (autologous) or from a donor (allograft). Autologous cells are favored in Orthobiologics procedures due to their superior compatibility with the patient's body. Genetically identical cells significantly reduce the risk of immune rejection.[1][2]

History

Orthopedic surgeons first documented the use of bone marrow aspirate to improve bone chips implants into nonunion fractures.[3] The term Orthobiologics was first cited in the 1990s, combining "ortho" (referring to orthopedics) and "biologics" (which refers to treatments derived from biological sources).[4] The field of orthobiologics developed as interest grew in using biologically derived substances. Biologic products gained traction as regenerative medicine and biotechnology advanced, allowing for new applications in orthopedics. By the early 2000s, the term was well-established within the orthopedic and sports medicine community, focusing on minimally invasive treatments that use natural healing agents.[5]

In 2013, researchers at Hospital for Special Surgery published the study "Clinical and MRI outcomes after platelet-rich plasma treatment for knee osteoarthritis" (2013)." The study presented early evidence that the therapy improved function and reduced pain and inflammation.[6]

Advancements in orthobiologics include using platelets, progenitor cells, or mesenchymal stromal cells (MSC), for musculoskeletal conditions affecting cartilage, muscle, tendons, ligaments, spinal disc, and bone. Some commonly used orthobiologics include platelet-rich plasma (PRP), concentrated bone marrow aspirate (cBMA), or adipose-derived therapies such as microfragmented fat tissue (MFAT). Innovations in cartilage regeneration also include techniques such as matrix-induced autologous chondrocyte implantation (MACI) and biomimetic scaffolds. Additionally, growth factors like bone morphogenetic proteins (BMP) are used to enhance bone regeneration.[2] While all the above are approved or cleared for clinical use, other orthobiologics, not yet cleared for use in the clinic but being currently investigated include the use of so-called birth tissues such as umbilical cord cells or amniotic-derived products, as well as other biological products like exosomes. Researchers are also evaluating other approaches such as 3D printing and gene therapy that can offer new treatments for orthopedic injuries and degenerative conditions.[7][2]

In 2022, researchers from multiple institutions conducted an 11-year review of 474 research articles on orthobiologics. The literature included 132 clinical, 271 nonclinical, and 71 peer-reviewed articles consisting of 244 platelet-rich plasma articles, 146 bone marrow aspirate articles, 72 adipose-derived cells articles, and 12 amniotic cells articles. The review concluded that advancements in the field of orthobiologics requires the establishment of minimum reporting standards and higher-quality studies on the topic.[8]

In 2024, researchers conducted a cohort study of 253 patients with knee osteoarthritis to test the effectiveness of platelet-rich plasma (PRP) injections with varying platelet concentrations. Patients were assigned to receive PRP with either high, medium, or low platelet concentration levels, and their outcomes were measured over time. Results showed a clear link between platelet concentration and treatment success: the low-platelet group had a 15% failure rate, while both medium- and high-platelet groups had only a 3.3% failure rate. All groups, however, experienced clinical improvement during the study period.[9]

Tissue sources

Common tissues and types of cells extracted for orthopedic biologic therapies include:[10]

Medical uses

Orthobiologics are employed in the treatment of acute musculoskeletal injuries and chronic degenerative conditions, including tendonitis and tendinosis, degenerative disc disease, delayed-healing bone fractures, plantar fasciitis, hip labral tears, cartilage injuries, muscle strains, meniscus tears, ligament sprains and tears, and osteoarthritis.[20]

Their therapeutic role is based on the ability to stimulate healing in musculoskeletal tissues.[21][22] Most act by releasing anti-inflammatory and immune-modulating factors that enhance the local tissue environment and promote repair.[21][23]

Orthobiologics may be administered as stand-alone treatments or as adjuncts to surgical procedures.[22][21][24]

Injectable

Platelet-rich plasma

Platelet-rich plasma (PRP) therapy concentrates platelets and growth factors, and they are used to decrease healing time in injured tissues. The therapy is a treatment modality for symptoms of osteoarthritis, tendon and ligament injuries, cartilage repair, and post-surgical recovery.

The therapy is used to decrease healing time for ligament sprains and tears alongside traditional treatments. Clinicians currently use PRP therapy to augment surgical repair of tendons, including rotator cuff tendon, Achilles tendon, and hip gluteal tendon. PRP is also used to treat chronic conditions such as tennis elbow and rotator cuff tendonitis.

Studies show PRP therapy can aid in managing symptoms in knee osteoarthritis patients by regulating inflammatory pathways.[25]

PRP therapy is used together with surgical interventions to further improve post-surgical recovery and tissue healing after orthopedic surgical procedures. It has been shown to reduce inflammation, lead to faster recoveries, and improve post-surgery healing.[26][2]

Bone marrow aspirate

Concentrated bone marrow aspirate (cBMA) injection is an autologous biologic treatment. Bone marrow contains a population of connective tissue progenitor cells. The patient's bone marrow is extracted, then the cells and growth factors are concentrated in a centrifuge. The concentrate is injected into a damaged area for tissue regeneration.[27]

Adipose tissue

Micro fragmented adipose tissue (MFAT) is an autologous biologic technique that uses fat cells to promote healing for joint injuries and certain conditions like osteoarthritis.[28][29]

Surgical

Orthobiologics are used to improve surgical outcomes by using biologics to stimulate healing in musculoskeletal tissues. They are used to stimulate healing during or after surgical procedures for soft tissue reconstruction, tendon and ligament repair, and bone grafts.[21]

Cartilage repair

Autologous chondrocyte implantation (ACI) is a surgical procedure used for cartilage repair in the knee joint. Healthy cartilage cells are harvested from the patient, cultured in a laboratory, then implanted into the damaged joint.[30] Similar to ACI, matrix-associated autologous chondrocyte implantation (MACI) iterates on the technique.

MACI combines cultured cells and biomimetic scaffolds to improve integration of the newly-formed cartilage tissue.[31] Clinicians use natural scaffold materials such as collagen, hyaluronic acid, chitosan, and alginate, as well as synthetic scaffold materials such as polylactic acid, polyglycolic acid, and polycaprolactone. Often, natural and synthetic materials are combined in hybrid scaffolds.[32]

Bone repair

The use of orthobiologics in in-bone healing involves synthetic bone grafts and bone morphogenetic proteins (BMPs).[33] BMPs are a group of growth factors known as cytokines. BMPs are often used with synthetic bone grafts. The synthetic bone grafts can be made from calcium phosphate, hydroxyapatite, and bioactive glass to imitate the natural bone matrix. These materials mimic the natural bone matrix and support bone cell proliferation.[34]

Regulation

In the United States, the Food and Drug Administration (FDA) regulates the use of orthobiologics. In addition, the Federal Trade Commission regulates all marketing and advertising claims about orthobiologics.[35]

In the European Union, the use of orthobiologics is regulated by the European Medicines Agency (EMA) and by the National Competent Authorities of the individual EU member states.[36]

Elsewhere, regulations vary by individual country.

Challenges

Orthobiologics faces challenges including regulatory hurdles, clinical evidence to support efficacy, industry standardization and detailed classification, and high costs.[37] Since orthobiologics is a developing area of medicine, many insurance providers consider it to be experimental and will not cover them, requiring patients to pay out of pocket.[38]

Further reading

See also

Regenerative medicine

References

  1. ↑ Costa, Fábio Ramos; Pires, Luyddy; Martins, Rubens Andrade; Santos, Márcia; Santos, Gabriel Silva; Lana, João Vitor; Costa, Bruno Ramos; Santos, Napoliane et al. (2025-04-02). "Orthobiologics Revisited: A Concise Perspective on Regenerative Orthopedics". Current Issues in Molecular Biology 47 (4): 247. doi:10.3390/cimb47040247. ISSN 1467-3045. PMID 40699646. 
  2. ↑ 2.0 2.1 2.2 2.3 Islam, Moh Tawhidul; Bulut, Dilber; Sharabidze, Zuka (2025-01-14). "Regenerative Medicine in Orthopaedic Surgery: Pioneering Advances and Their Applications" (in en-GB). EMJ Innov Innovations 9.1 2025 9 (1): 82–94. doi:10.33590/emjinnov/FGDS3814. ISSN 2513-8634. https://www.emjreviews.com/en-us/amj/innovations/article/regenerative-medicine-in-orthopaedic-surgery-pioneering-advances-and-their-applications/. 
  3. ↑ Griswold, R. Arnold (1939). "The Treatment of Delayed Union and Nonunion of Fractures by Subcutaneous Drilling". Annals of Surgery 109 (1): 135–142. doi:10.1097/00000658-193901000-00013. ISSN 0003-4932. PMID 17857304. 
  4. ↑ Dhillon, Mandeep S.; Patel, Sandeep (2022). "Why OrthoBiologics?". Journal of Clinical Orthopaedics and Trauma 28. doi:10.1016/j.jcot.2022.101850. ISSN 0976-5662. PMID 35392032. 
  5. ↑ Vaish, Abhishek; Murrell, William; Vaishya, Raju (2020-07-15). "History of regenerative medicine in the field of orthopedics" (in en). Journal of Arthroscopic Surgery and Sports Medicine 1 (1): 154–158. doi:10.25259/JASSM_12_2020. ISSN 0000-0000. https://jassm.org/history-of-regenerative-medicine-in-the-field-of-orthopedics/. 
  6. ↑ Halpern, Brian; Chaudhury, Salma; Rodeo, Scott A.; Hayter, Catherine; Bogner, Eric; Potter, Hollis G.; Nguyen, Joseph (2013). "Clinical and MRI outcomes after platelet-rich plasma treatment for knee osteoarthritis". Clinical Journal of Sport Medicine 23 (3): 238–239. doi:10.1097/JSM.0b013e31827c3846. ISSN 1536-3724. PMID 23238250. 
  7. ↑ Goulian, Andrew J.; Goldstein, Brielle; Saad, Maarouf A. (2025-03-18). "Advancements in Regenerative Therapies for Orthopedics: A Comprehensive Review of Platelet-Rich Plasma, Mesenchymal Stem Cells, Peptide Therapies, and Biomimetic Applications". Journal of Clinical Medicine 14 (6): 2061. doi:10.3390/jcm14062061. ISSN 2077-0383. PMID 40142869. 
  8. ↑ Obana, Kyle K.; Schallmo, Michael S.; Hong, Ian S.; Ahmad, Christopher S.; Moorman, Claude T.; Trofa, David P.; Saltzman, Bryan M. (2022). "Current Trends in Orthobiologics: An 11-Year Review of the Orthopaedic Literature". The American Journal of Sports Medicine 50 (11): 3121–3129. doi:10.1177/03635465211037343. ISSN 1552-3365. PMID 34528456. 
  9. ↑ Boffa, Angelo; De Marziani, Luca; Andriolo, Luca; Di Martino, Alessandro; Romandini, Iacopo; Zaffagnini, Stefano; Filardo, Giuseppe (2024). "Influence of Platelet Concentration on the Clinical Outcome of Platelet-Rich Plasma Injections in Knee Osteoarthritis". The American Journal of Sports Medicine 52 (13): 3223–3231. doi:10.1177/03635465241283463. ISSN 1552-3365. PMID 39397728. 
  10. ↑ "Orthobiologics" (in en). https://stanfordhealthcare.org/medical-treatments/o/orthobiologics.html. 
  11. ↑ Mazini, Loubna; Ezzoubi, Mohamed; Malka, Gabriel (2021-01-04). "Overview of current adipose-derived stem cell (ADSCs) processing involved in therapeutic advancements: flow chart and regulation updates before and after COVID-19". Stem Cell Research & Therapy 12 (1). doi:10.1186/s13287-020-02006-w. ISSN 1757-6512. PMID 33397467. 
  12. ↑ "Bone Marrow Aspirate Concentrate: Its Uses in Osteoarthritis". International Journal of Molecular Sciences 21 (9): 3224. May 2020. doi:10.3390/ijms21093224. PMID 32370163. 
  13. ↑ "Mesenchymal Stem Cell Therapy for Bone Regeneration". Clinics in Orthopedic Surgery 10 (3): 271–278. September 2018. doi:10.4055/cios.2018.10.3.271. PMID 30174801. 
  14. ↑ "An overview of mesenchymal stem cells and their potential therapeutic benefits in cancer therapy". Oncology Letters 22 (5): 785. November 2021. doi:10.3892/ol.2021.13046. PMID 34594426. 
  15. ↑ "Bone Marrow Mesenchymal Stromal Cells: Identification, Classification, and Differentiation". Frontiers in Cell and Developmental Biology 9. 2021. doi:10.3389/fcell.2021.787118. PMID 35047499. 
  16. ↑ "Hematopoietic Stem Cells and Their Niche in Bone Marrow". International Journal of Molecular Sciences 25 (13): 6837. June 2024. doi:10.3390/ijms25136837. PMID 38999948. 
  17. ↑ "Bone marrow niches for hematopoietic stem cells". HemaSphere 8 (8). August 2024. doi:10.1002/hem3.133. PMID 39086665. 
  18. ↑ Dragoo, Jason L. (2016-07-01). "The Use of Platelet-Rich and Platelet-Poor Plasma to Enhance Differentiation of Skeletal Myoblasts: Implications for the Use of Autologous Blood Products for Muscle Regeneration" (in en). Orthopaedic Journal of Sports Medicine 4 (7_suppl4). doi:10.1177/2325967116S00150. ISSN 2325-9671. 
  19. ↑ Sawvell, Emily; Wright, Noah; Ode, Gabriella; Mercuri, Jeremy (2022). "Perinatal Tissue-Derived Allografts and Stromal Cells for the Treatment of Knee Osteoarthritis: A Review of Preclinical and Clinical Evidence". Cartilage 13 (4): 184–199. doi:10.1177/19476035221137725. ISSN 1947-6043. PMID 36398763. 
  20. ↑ "Orthobiologics and Regenerative Medicine" (in en-US). https://med.stanford.edu/ortho/clinics/orthobiologics.html. 
  21. ↑ 21.0 21.1 21.2 21.3 "Orthobiologics Revisited: A Concise Perspective on Regenerative Orthopedics". Current Issues in Molecular Biology 47 (4): 247. April 2025. doi:10.3390/cimb47040247. PMID 40699646. 
  22. ↑ 22.0 22.1 "Orthobiologics: Current role in Orthopedic Surgery and Traumatology". The Archives of Bone and Joint Surgery 10 (7): 536–542. July 2022. doi:10.22038/ABJS.2021.52770.2614. PMID 36032640. 
  23. ↑ "An update on the use of Orthobiologics: use of biologics for osteoarthritis.". Operative Techniques in Sports Medicine 28 (3). September 2020. doi:10.1016/j.otsm.2020.150759. 
  24. ↑ "An update on the use of orthobiologics combined with corrective osteotomies for osteoarthritis: osteotomy site and intra-articular efficacy.". Operative Techniques in Sports Medicine 30 (3). September 2022. doi:10.1016/j.otsm.2022.150933. 
  25. ↑ Blaga, Florin Nicolae; Nutiu, Alexandru Stefan; Lupsa, Alex Octavian; Ghiurau, Nicu Adrian; Vlad, Silviu Valentin; Ghitea, Timea Claudia (2024-08-09). "Exploring Platelet-Rich Plasma Therapy for Knee Osteoarthritis: An In-Depth Analysis". Journal of Functional Biomaterials 15 (8): 221. doi:10.3390/jfb15080221. ISSN 2079-4983. PMID 39194659. 
  26. ↑ Fang, Jie; Wang, Xin; Jiang, Wen; Zhu, Yaqiong; Hu, Yongqiang; Zhao, Yanxu; Song, Xueli; Zhao, Jinjuan et al. (2020). "Platelet-Rich Plasma Therapy in the Treatment of Diseases Associated with Orthopedic Injuries". Tissue Engineering. Part B, Reviews 26 (6): 571–585. doi:10.1089/ten.TEB.2019.0292. ISSN 1937-3376. PMID 32380937. 
  27. ↑ Chahla, Jorge; Mannava, Sandeep; Cinque, Mark E.; Geeslin, Andrew G.; Codina, David; LaPrade, Robert F. (2017). "Bone Marrow Aspirate Concentrate Harvesting and Processing Technique". Arthroscopy Techniques 6 (2): e441–e445. doi:10.1016/j.eats.2016.10.024. ISSN 2212-6287. PMID 28580265. 
  28. ↑ Fu, Hongjuan; Wang, Congcong (2025-02-28). "Micro-fragmented adipose tissue-An innovative therapeutic approach: A narrative review". Medicine 104 (9). doi:10.1097/MD.0000000000041724. ISSN 1536-5964. PMID 40020111. 
  29. ↑ Screpis, Daniele; Natali, Simone; Farinelli, Luca; Piovan, Gianluca; Iacono, Venanzio; de Girolamo, Laura; Viganò, Marco; Zorzi, Claudio (2022-02-25). "Autologous Microfragmented Adipose Tissue for the Treatment of Knee Osteoarthritis: Real-World Data at Two Years Follow-Up". Journal of Clinical Medicine 11 (5): 1268. doi:10.3390/jcm11051268. ISSN 2077-0383. PMID 35268359. 
  30. ↑ "Chapter 1, Background.". Autologous chondrocyte implantation in the knee: systematic review and economic evaluation.. Southampton (UK): NIHR Journals Library. February 2017. Health Technology Assessment, No. 21.6.. https://www.ncbi.nlm.nih.gov/books/NBK424071/. 
  31. ↑ "Learn About MACI Science & Data | MACI®". https://www.maci.com/healthcare-professionals/about-maci/. 
  32. ↑ Zhao, Xia; Hu, Daniel A.; Wu, Di; He, Fang; Wang, Hao; Huang, Linjuan; Shi, Deyao; Liu, Qing et al. (2021). "Applications of Biocompatible Scaffold Materials in Stem Cell-Based Cartilage Tissue Engineering". Frontiers in Bioengineering and Biotechnology 9. doi:10.3389/fbioe.2021.603444. ISSN 2296-4185. PMID 33842441. 
  33. ↑ "Bone grafts, bone substitutes and orthobiologics: the bridge between basic science and clinical advancements in fracture healing". Organogenesis 8 (4): 114–24. 2012. doi:10.4161/org.23306. PMID 23247591. 
  34. ↑ Gillman, Cassidy E.; Jayasuriya, Ambalangodage C. (2021). "FDA-approved bone grafts and bone graft substitute devices in bone regeneration". Materials Science & Engineering. C, Materials for Biological Applications 130. doi:10.1016/j.msec.2021.112466. ISSN 1873-0191. PMID 34702541. 
  35. ↑ Murray, Iain R.; Chahla, Jorge; Wordie, Sarah J.; Shapiro, Shane A.; Piuzzi, Nicolas S.; Frank, Rachel M.; Halbrecht, Joanne; Okada, Kiyoshi et al. (2022). "Regulatory and Ethical Aspects of Orthobiologic Therapies". Orthopaedic Journal of Sports Medicine 10 (11). doi:10.1177/23259671221101626. ISSN 2325-9671. PMID 36479465. 
  36. ↑ Sebbagh, Patrick; Cannone, Alessandro; Gremion, Gerald; Gremeaux, Vincent; Raffoul, Wassim; Hirt-Burri, Nathalie; Michetti, Murielle; Abdel-Sayed, Philippe et al. (2023-02-24). "Current Status of PRP Manufacturing Requirements & European Regulatory Frameworks: Practical Tools for the Appropriate Implementation of PRP Therapies in Musculoskeletal Regenerative Medicine" (in en). Bioengineering 10 (3): 292. doi:10.3390/bioengineering10030292. ISSN 2306-5354. PMID 36978683. 
  37. ↑ Jeyaraman, Madhan; Muthu, Sathish; Amarnath, S. S. (2024). "Barriers and Solutions Towards Integrating Orthobiologics into Clinical Orthopaedic Practice". Indian Journal of Orthopaedics 58 (8): 987–990. doi:10.1007/s43465-024-01221-4. ISSN 0019-5413. PMID 39087048. 
  38. ↑ Ponce, Brent; McGee, Andrew; Dombrowsky, Alex; Waldrop, Raymond; Wild, Joshua; Faroqui, Naqeeb; Huntley, Samuel Roswell; McCollough, Kennieth Charles et al. (2019-07-01). "The Cost Variability of Orthobiologics" (in en). Orthopaedic Journal of Sports Medicine 7 (7_suppl5). doi:10.1177/2325967119S00285. ISSN 2325-9671. 



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