Table 2.
Clinical trials of bioactive peptides and proteins (BAPPs) in tissue regeneration
| Clinical trials | Conditions | Participants (age/gender) | BAPPs | Overcome | Phase | Study time |
|---|---|---|---|---|---|---|
| EudraCT 2008–000592-24 | Newly formed bone after tibia distraction osteogenesis | 16 (25 + /both) | PTH 1-34 | Teriparatide treatment doubled bone regeneration when compared to no treatment | - | 2009–2013 |
| NCT01279187 | Craniofacial osseous regeneration in bone | 27 (30–85/both) | Teriparatide | - | Phase II | 2011–2015 |
| NCT00533793 | Tibial shaft fractures | 201 (adults, elder/both) | TGplPTH 1-34 | - | Phase II | 2007–2011 |
| NCT04294004 | Degenerative disc disease | 50 (25–75/both) | TGplPTH 1-34 | - | Phase II | 2020–2025 |
| NCT01033994 | Knee osteoarthritis | 192 (40 + /adults, elder/both) | Sprifermin | - | Phase I | 2008–2010 |
| NCT01066871 | Acute cartilage injury of the knee | 74 (18–45/both) | Sprifermin (AS902330) | - | Phase II | 2010–2013 |
| NCT01689337 | Grade 3 degenerative joint disease of the knee | 102 (18–70 adults, elder/both) | Sprifermin | - | Phase II | 2011–2014 |
| NCT05276011 | Hip osteoarthritis | 255 (18–80 adults, elder/both) | Sprifermin | - | Phase II | 2024–2025 |
| NCT02491281 | Cartilage repair in primary osteoarthritis | 28 (50–75 adults, elder/both) | LNA043 | - | Phase I | 2015–2018 |
| NCT03275064 | Articular cartilage lesions | 142 (18–75 adults, elder/both) | LNA043 | - | Phase II | 2017–2022 |
| NCT04864392 | Knee osteoarthritis | 581 (40–75 adults, elder/both) | LNA043 | - | Phase II | 2021–2027 |
| NCT04814368 | Knee osteoarthritis | 24 (40–80 adults, elder/both) | LNA043 | - | Phase II | 2021–2024 |
| NCT01124006 | Early lumbar disc degeneration | 24 (adults, elder/both) | RhGDF-5 | - | Phase II | 2010–2014 |
| NCT01158924 | Early lumbar disc degeneration | 40 (adults, elder/both) | RhGDF-5 | - |
Phase I Phase II |
2010–2016 |
| NCT00813813 | Early lumbar disc degeneration | 32 (adults, elder/both) | RhGDF-5 | - |
Phase I Phase II |
2008–2013 |
| NCT01182337 | Early lumbar disc degeneration | 31 (adults, elder/both) | RhGDF-5 | - |
Phase I Phase II |
2010–2014 |
| NCT03708926 | Lumbar disc degeneration | - (adults, elder/both) | Abaloparatide | - | Phase II | 2021–2024 |
| NCT01207908 | Duchenne muscular dystrophy | 44 (5 + adults, elder/both) | IGF-1 | - |
Phase I Phase II |
2010–2013 |
| NCT00577577 | Myotonic dystrophy type 1 | 69 (21–65 adults, elder/both) |
rhIGF-I rhIGFBP-3 |
- | Phase II | 2007–2008 |
| NCT00233519 | Myotonic dystrophy type 1 | 17 (21–60 adults/both) |
rhIGF-I rhIGFBP-3 |
- |
Phase I Phase II |
2005–2008 |
| NCT01834989 | Patellar tendinopathy | 40 (18–50 adults/both) | IGF-1 | - | Early phase I | 2013–2020 |
| NCT00936559 | Rotator cuff repair | 13 (25–75 adults, elder/both) | BMP-12 | - | Phase I | 2010–2012 |
| NCT01122498 | Gingival recession defects | 30 (20–55 adults/both) | BMP-12 | - | Phase I | 2019–2021 |
| NCT04375618 | Gingival recession defects | 30 (20–55 adults/both) | RhEGF | - | Phase I | 2019–2021 |
| NCT02236793 | Chronic diabetic foot ulcer | 252 (adults, elder/both) | PDGF-BB | - | Phase III | 2014–2016 |
| NCT01098357 | Chronic diabetic foot ulcer | 192 (18–75 adults, elder/both) | PDGF-BB | - |
Phase I Phase II |
2010–2011 |
| NCT03037970 | Chronic diabetic foot ulcer | 40 (30–75 adults, elder/both) | RhPDGF-BB | - | Phase II | 2017 |
| NCT00740922 | Chronic diabetic foot ulcer | 563 (adults, elder/both) | RhPDGF-BB | - | Observational | 1999–2001 |
| NCT00812513 | Healing wounds caused by third-degree thermal and electrical burns | 120 (18–75 adults, elder/both) | R-Pdf/Gbb | - | Phase II | 2011–2012 |
| NCT00847925 | Wound healing | 103 (18–45 adults/male) | Juvista | - |
Phase I Phase II |
2001–2003 |
| NCT00629811 | Wound healing | 78 (18–85 adults, elders/both) | Juvista | - | Phase II | 2006–2007 |
| NCT00847795 | Wound healing | 42 (60 + adults, elders/both) | Juvista | - |
Phase I Phase II |
2002–2003 |
| NCT00430326 | Wound healing | 156 (18–85 adults, elders/both) | Juvista | - | Phase II | 2006–2009 |
| NCT00594581 | Wound healing | 71 (18–85 adults, elders/both) | Juvista | - | Phase II | 2003–2005 |
| NCT00432211 | Scar appearance following scar revision surgery | 60 (18–85 adults, elder/both) | Juvista | - |
Phase I Phase II |
2006–2012 |
| NCT00117936 | Coronary heart disease | 150 (25–75 adults, elder/both) | FGF1–141 | - | Phase II | 2020–2023 |
| NCT03686163 | Acute ischemic stroke | 106 (adults, elder/both) | NGF | - | Phase IV | 2016–2020 |
| NCT04041349 | Cerebral small vessel disease | 510 (50–80 adults, elder/both) | mNGF | - | Phase IV | 2019–2021 |
| NCT02490501 | Traumatic spinal cord injury | 27 (18–65 adults, elder/both) | FGF-1 | - |
Phase I Phase II |
2015–2020 |
| NCT06328166 | Carpal tunnel syndrome | 28 (18–80 adults, elder/both) |
ES135 (RhFGF-1) |
- | Not applicable | 2024 |
| NCT02193334 | Acute spinal cord injury | 45 (18–75 adults, elder/both) |
KP-100IT (HGF) |
- |
Phase I Phase II |
2014–2018 |
| NCT04475224 | Acute spinal cord Injury | 25 (18–89 adults, elder/both) |
KP-100IT (HGF) |
- | Phase III | 2020–2023 |
| NCT04100655 | Endometrial thickness in infertile women | 96 (18–40 adults/both) | GM-CSF | - | Not applicable | 2019–2020 |
| NCT03023774 | Recurrent Ivf/Icsi failure | 20 (child, adults/female) | GM-CSF | - | Not applicable | 2016 |
| NCT01202643 | Poor endometrial development during IVF | 12 (21–45 adults/female) | GM-CSF | - |
Phase I Phase II |
2010–2013 |
GM-CSF granulocyte–macrophage colony-stimulating factor, RhBMP recombinant human bone morphometric proteins, PTH 1–34 parathyroid hormone 1–34, IGFBP-3 recombinant human IGF binding protein-3, IGF-1 insulin-like growth factor-1, HGF hepatocyte growth factor, RhPDGF-BB recombinant human platelet-derived growth factor-BB, FGF-1 fibroblast growth factor-1, NGF nerve growth Factor, RhEGF recombinant human epidermal growth factor, RhGDF-5 recombinant human growth differentiation factor-5