NCT01362413 - 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)

Arvidson K, Abdallah BM, Applegate LA, Baldini N, Cenni E, Gomez-Barrena E, Granchi D, Kassem M, Konttinen YT, Mustafa K, Pioletti DP, Sillat T, Finne-Wistrand A
Bone regeneration and stem cells. J Cell Mol Med. 2011 Apr;15(4):718-46. doi: 10.1111/j.1582-4934.2010.01224.x. Review.
Calori GM, Tagliabue L, Gala L, d'Imporzano M, Peretti G, Albisetti W
Application of rhBMP-7 and platelet-rich plasma in the treatment of long bone non-unions: a prospective randomised clinical study on 120 patients. Injury. 2008 Dec;39(12):1391-402. doi: 10.1016/j.injury.2008.08.011. Epub 2008 Nov 22.
Cenni E, Savarino L, Perut F, Fotia C, Avnet S, Sabbioni G
Background and rationale of platelet gel in orthopaedic surgery. Musculoskelet Surg. 2010 May;94(1):1-8. doi: 10.1007/s12306-009-0048-9. Epub 2009 Nov 24. Review.
De Bari C, Dell'Accio F, Karystinou A, Guillot PV, Fisk NM, Jones EA, McGonagle D, Khan IM, Archer CW, Mitsiadis TA, Donaldson AN, Luyten FP, Pitzalis C
A biomarker-based mathematical model to predict bone-forming potency of human synovial and periosteal mesenchymal stem cells. Arthritis Rheum. 2008 Jan;58(1):240-50. doi: 10.1002/art.23143.
Gandhi A, Bibbo C, Pinzur M, Lin SS
The role of platelet-rich plasma in foot and ankle surgery. Foot Ankle Clin. 2005 Dec;10(4):621-37, viii. Review.
Granchi D, Devescovi V, Baglìo SR, Leonardi E, Donzelli O, Magnani M, Stilli S, Giunti A, Baldini N
Biological basis for the use of autologous bone marrow stromal cells in the treatment of congenital pseudarthrosis of the tibia. Bone. 2010 Mar;46(3):780-8. doi: 10.1016/j.bone.2009.10.044. Epub 2009 Nov 10.

Validation of Laboratory Test for Predicting Bone Tissue Regeneration in Patient Affected by Aseptic Pseudarthrosis and Treated With Platelet Gel

Details for clinical trial NCT01362413

Clinical trial NCT01362413 - References