NCT04200872 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Dallari D, Savarino L, Stagni C, Cenni E, Cenacchi A, Fornasari PM, Albisinni U, Rimondi E, Baldini N, Giunti A
Enhanced tibial osteotomy healing with use of bone grafts supplemented with platelet gel or platelet gel and bone marrow stromal cells. J Bone Joint Surg Am. 2007 Nov;89(11):2413-20. doi: 10.2106/JBJS.F.01026.
Krishnakumar GS, Roffi A, Reale D, Kon E, Filardo G
Clinical application of bone morphogenetic proteins for bone healing: a systematic review. Int Orthop. 2017 Jun;41(6):1073-1083. doi: 10.1007/s00264-017-3471-9. Epub 2017 Apr 19.

Retrospective Study on the Clinical Outcomes of the Aseptic Pseudarthrosis Treatment of the Upper Limb

Clinical trial NCT04200872 - References