NCT02904824 - 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)

Cantarella G, Mazzola RF, Domenichini E, Arnone F, Maraschi B
Vocal fold augmentation by autologous fat injection with lipostructure procedure. Otolaryngol Head Neck Surg. 2005 Feb;132(2):239-43.
Gómez P, Fernández R, Rodellar V, Nieto V, Álvarez A, Mazaira LM, Martínez R
, Godino JI. Glottal Source Biometrical Signature for Voice Pathology Detection, Speech Communication; 51 2009, pp 759-781.
Pérez-Cano R, Vranckx JJ, Lasso JM, Calabrese C, Merck B, Milstein AM, Sassoon E, Delay E, Weiler-Mithoff EM
Prospective trial of adipose-derived regenerative cell (ADRC)-enriched fat grafting for partial mastectomy defects: the RESTORE-2 trial. Eur J Surg Oncol. 2012 May;38(5):382-9. doi: 10.1016/j.ejso.2012.02.178. Epub 2012 Mar 15.
Rosen CA, Lee AS, Osborne J, Zullo T, Murry T
Development and validation of the voice handicap index-10. Laryngoscope. 2004 Sep;114(9):1549-56.
Zhu M, Zhou Z, Chen Y, Schreiber R, Ransom JT, Fraser JK, Hedrick MH, Pinkernell K, Kuo HC
Supplementation of fat grafts with adipose-derived regenerative cells improves long-term graft retention. Ann Plast Surg. 2010 Feb;64(2):222-8. doi: 10.1097/SAP.0b013e31819ae05c.

Injection Laryngoplasty Using Autologous Fat Enriched With Adipose Derived Regenerative Stem Cells (ADRC) vs Centrifuged Autologous Fat (CAF), for the Functional Reconstruction of the Glottal Gap After Unilateral Vocal Cord Paralysis

Details for clinical trial NCT02904824

Clinical trial NCT02904824 - References