Table 4.
Examples of FDA approval of clinical trials in TE.
| Biomaterial | Clinical Trial | Aim of Study | ID Number |
|---|---|---|---|
| Bioengineered Bilayered Living Cellular Construct | A bioengineered living-cell construct activates an acute wound-healing response in venous leg ulcers |
Treatment of Chronic nonhealing venous leg ulcers (VLUs) |
NCT01327937 (2017) |
| Tricalcium Phosphate | EUDRA-CT | Atrophic Nonunion of long bones |
NCT02483364 (2020) |
| Hydroxyapatite + collagen | A multilayer biomaterial for osteochondral regeneration shows superiority vs. microfractures for the treatment of osteochondral lesions in a multicenter randomized trial at 2 years | Assess the benefit provided by a nanostructured collagen–hydroxyapatite (coll-HA) multilayer scaffold for the treatment of chondral and osteochondral knee lesions |
NCT01282034 (2021) |
| Carbon nanomaterials | Carbon nanomaterials for cardiovascular theranostics: promises and challenges | Drug-delivery Biosensor Tissue engineering Immunomodulation |
NCT02698163 (2016) |
| Autologous cartilage cells expanded ex vivo | Autologous chondrocyte implantation (ACI) in the knee: systematic review and economic evaluation | Assess the clinical effectiveness and cost-effectiveness of ACI in chondral defects in the knee, compared with microfracture (MF) | TIG/ACT/01/2000 (2017) |
| Collagen Alginate Dressing | Omega3 Wound Fish Skin Graft in the Treatment of DFUs | Treatment of diabetic foot ulcers (DFUs) |
NCT04133493 (2019 to 2022) |
| Platelet-Rich Plasma (PRP) |
Study on the healing of the partial skin-graft donor site in burn patients | Skin burn regeneration | 2016-000968-42 (2016) |
| Mucopolysaccharides (Hyaluronic acid + Chondroitin sulfate) | Regeneration of ischemic damage in the cardiovascular system using Wharton’s jelly as an unlimited source of mesenchymal stem cells for regenerative medicine | Regeneration of cardiovascular damaged tissue | 2016-004684-40 (2018) |
| Autologous Chondrocyte implantation product | A Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D Plus Compared to Microfracture in the Treatment of Articular Cartilage Defects of the Knee. | Repair of localized, full-thickness cartilage defects of the femoral condyle (medial, lateral, or trochlea) of 2–6 cm2 | 2011-005798-22 (2012) |