NCT06459817 - 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)

Adravanti P, Nicoletti S, Setti S, Ampollini A, de Girolamo L
Effect of pulsed electromagnetic field therapy in patients undergoing total knee arthroplasty: a randomised controlled trial. Int Orthop. 2014 Feb;38(2):397-403. doi: 10.1007/s00264-013-2216-7
Benazzo F, Cadossi M, Cavani F, Fini M, Giavaresi G, Setti S, Cadossi R, Giardino R
Cartilage repair with osteochondral autografts in sheep: effect of biophysical stimulation with pulsed electromagnetic fields. J Orthop Res. 2008 May;26(5):631-42. doi: 1
Cadossi M, Buda RE, Ramponi L, Sambri A, Natali S, Giannini S
Bone marrow-derived cells and biophysical stimulation for talar osteochondral lesions: a randomized controlled study. Foot Ankle Int. 2014 Oct;35(10):981-7. doi: 10.1177/1071100714539660. Epub
Moretti L, Bizzoca D, Giancaspro GA, Cassano GD, Moretti F, Setti S, Moretti B
Biophysical Stimulation in Athletes' Joint Degeneration: A Narrative Review. Medicina (Kaunas). 2021 Nov 4;57(11):1206. doi: 10.3390/medicina57111206.
Perdisa F, Bordini B, Salerno M, Traina F, Zaffagnini S, Filardo G
Total Knee Arthroplasty (TKA): When Do the Risks of TKA Overcome the Benefits? Double Risk of Failure in Patients up to 65 Years Old. Cartilage. 2023 Sep;14(3):305-311. doi: 10.1177/19476

Quantitative Assessment of BB-02 Therapy Effect on Cartilage Status in Patients Affected by Early Knee Osteoarthritis

Clinical trial NCT06459817 - References