Table 3 Clinical trials using biologics to treat nonunions
From: Biologics for bone regeneration: advances in cell, protein, gene, and mRNA therapies
Biologic | Details | Place | ID /Status |
|---|---|---|---|
Human Amniotic Epithelial Cells (hAECs) | - For limbs nonunions. - hAECs obtained from the epiblast as early as 8 days after fertilization. - 50 million cells transplanted to nonunion site after debridement surgery. | Shanghai, China | NCT03031509 Unknown |
Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) | - For traumatic noninfectious bone nonunions or delayed bone unions, with no obvious callus growth 8 months after local bone grafting. - 2 mL with 100 million cells, once every two weeks, 3 times in total. | Jinan, Shandong, China | NCT04997590 Unknown |
Mesenchymal Stem Cells (MSCs) | - For tibial and femoral nonunions having no radiological callus after 6 months. -2-3 mL with approximately 40 million cells. | Mashhad, Khorasan, Iran, | NCT01788059 Completed |
Bone Marrow-derived Mesenchymal Stem Cell (BMSCs) | - Nonunion or delayed union with more than 4 cm distance to joint. | Tehran, Iran | NCT01206179 Completed |
Reamer Irrigator Aspirator (RIA) vs Autogenous Iliac Crest Bone Graft (AICBG) | - For nonunion of a long bone requiring bone grafting. - RIA to harvest bone graft from the femoral canal. | Toronto, Canada | NCT01382485 Unknown |
Adipose Tissue Derived Stromal Vascular Fraction (SVF) | - For nonunion of long bones or delayed union diagnosed with more than 4 cm distance from the joint. - Heterogeneous cell population (20% CD105+ MSCs, 40% CD34+ hematopoietic cells). | Rudrapur, India | NCT04340284 Completed |
Bone Marrow Mononuclear Cells | - For long bone nonunion. - Obtained by posterosuperior iliac crest aspiration and isolated by Ficoll density gradient. | Oviedo, Spain | NCT01581892 Completed |
Bone Marrow Mononuclear Cells | - For long bone nonunion of lower extremities (femur and tibia). - Implanted in collagenic 3-D scaffold with BMP-2. | Khorasan, Iran | NCT01958502 Unknown |
NVD-003 (Autologous stem cells) | - For lower limb nonunion. - Stem cells embedded in their self-secreted extracellular matrix, combined with hydroxyapatite/beta-tricalcium phosphate particles, cocktail of growth factors, and miRNAs. | Belgium, Luxembourg, Switzerland | NCT06335394 Active |
XCEL-MT-OSTEO-ALPHA | - ex vivo expanded autologous MSCs For atrophic nonunion of long bones. - Fixed in allogenic bone tissue. | Barcelona, Spain | NCT02230514 Completed |
Tissue-Engineered Bone (with BMSCs) | - For bone nonunion caused by tumor or trauma. - BMSC in porous β-tricalcium phosphate scaffold. - 3.4 million cells in 10 mL serum-free medium seeded onto scaffold and co-cultured for two weeks. | Xi’an, China | NCT02748343 Unknown |
BMSCs | - For post-traumatic nonunion. - Cells cultured are seeded on a collagen scaffold, included into autologous platelet-rich plasma (PRP) clot. | Caracas, Venezuela | NCT06103396 Active |
Preosteoblast Cells | - For long bone nonunion. - Cells obtained from 50 mL of bone marrow harvest and culture for 3 weeks. | Liege, Belgium | NCT00916981 Completed |
MSCs | - For atrophic nonunion of long bones. - Patient transplanted with stem cells and hydroxyapatite. | Jakarta, Indonesia | NCT01626625 Unknown |
Vivigen Cellular Bone Matrix | - Contains lineage-committed bone cells (osteoblasts and osteocytes) within a corticocancellous bone matrix and demineralized bone. - For acute fracture, delayed, nonunion. | Several locations in the US | NCT04299022 Active |
Autologous BMSC Transplantation in Combination with Platelet Lysate | - For nonunion fracture of tibial midshaft. | Tehran, Iran | NCT02448849 Unknown |
2 Doses of Autologous BMSC+Biomaterial vs Iliac Crest AutoGraft | - For humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture nonunions. - Low Dose BMSC: 100 million cells. - High Dose BMSC: 200 million cells. - Biomaterial: biphasic calcium phosphate granules. | Multiple locations in Germany, Italy, and Spain | NCT03325504 Completed |
Mononucleotide Autologous Stem Cells | - Tibial or femur nonunions. - A demineralized bone matrix using Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology. | Jerusalem, Israel | NCT01435434 Unknown |
rhBMP-2 or rhBMP-7 | - For acute long bone fractures or nonunions. | Munich Germany | NCT05065684 Completed |
rhBMP-2 vs Autologous Bone Grafting | - For nonunion of the docking site of long bones. | Leuven, Belgium | NCT01756144 Unknown |
Gene-activated Bone Substitute | - For long bone nonunions: Gustilo I and II, IIIA and IIIB humerus, tibial or femur fracture. - Gene-activated matrix based on octacalcium phosphate and plasmid DNA encoding VEGFA gene, mixed with shredded autobone. | Saint Petersburg, Russian Federation | NCT04705857 Unknown |
