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Dinaki et al. | Journal of Clinical and Translational Research 2024; 10(2): 99-111 103
Table 3. Clinical trials of TMP treatment with MSCs, scaffolds, and growth factors
Author Number of patients/study model Treatment Outcome
Raj et al., 2011 [40] 42 patients; two groups: 21 Tympanoplasty type 1 with There were no significant differences in
patients per group acellular dermis was performed terms of the graft success rate and hearing
in one group, and type 1 improvement. However, the acellular dermis
tympanoplasty with temporal had a shorter operative time and lesser
fascia was performed in the other postoperative pain.
group (control).
Kanemaru et al., 2011 [35] 63 patients; two groups: 53 were Fibrin glue and gelatin sponge There were significantly greater rates of TMP
assigned to the bFGF group and with bFGF were used in the bFGF closure in the bFGF group.
10 were assigned to the control group.
group
Roosli et al., 2011 [41] 20 patients; two groups: 10 in Topical PDGF application on There were no significant differences in terms
the placebo group and 10 in the TMPs in the intervention group. of success rate (reduction of perforation size
intervention group by 50% or more) and hearing thresholds
between the two groups.
Lou et al., 2012 [42] 94 patients; three groups: (1) Topical FGF, Gelfoam with FGF. The closure rates in the FGF-treated groups
direct FGF application, (2) FGF were significantly increased as compared to
via Gelfoam, and (3) control the control group, but there was no difference
group in closure rates in patients who received FGF
directly and those who received FGF through
Gelfoam.
Lou and Wang, 2015 [33] 93 patients; two groups: Topical bFGF application. There were significantly higher rates of
randomized into control and closure and shorter closure times in the
bFGF-treated groups bFGF-treated group than in the control group.
Lou et al., 2016 [43] 86 patients; three groups:(1) EGF, Topical bFGF and EGF There was no substantial difference in the
(2) bFGF, and (3) control group application. closure rates and closure times between the
bFGF, EGF, and control groups.
Lou et al., 2016 [44] 97 patients; two groups: topical Topical EGF application. The total closure rates did not significantly
application of EGF in one group differ between the two groups. The total
and a control group average closure time in the control group was
significantly longer than in the EGF group.
Lou and Lou, 2017 [32] 184 patients; four groups: (1) EGF EGF, FGF-2, and ofloxacin drops The three treatment groups exhibited
treatment, (2) FGF-2 treatment, 0.3% were applied in the three significantly shorter closure times as
(3) 0.3% ofloxacin drops treatment groups, respectively. compared to the control group. Neither
treatment, and (4) control group the closure rate nor closure time differed
significantly among the three treatment
groups.
Zheng Cai et al., 2018 [34] 134 patients; two groups: FGF-2 application on TMP in the The overall closure rate was significantly
randomly divided into a control treatment group. different between the FGF-2 treatment group
group and an FGF-2 treatment and the control group. The FGF treatment
group group had a considerably shorter closure time
than the control group.
Kanemaru et al., 2021 [45] 20 patients; non-randomized, A gelatin sponge with bFGF and At 16 weeks, complete closure of the TMP
single-arm study fibrin glue was applied. was observed in 15 of 20 patients, and the
ratio of hearing improvement and air-bone
gap was 100%.
Lou et al., 2021 [46] 29 patients; two groups: 13 in the bFGF application in one group. It was indicated that bFGF alone facilitated
bFGF alone group and 16 in the the repair of chronic and small TMPs but was
myringoplasty group ineffective for medium-sized TMPs.
Abbreviations: bFGF: basic fibroblast growth factor; EGF: Epidermal growth factor; FGF: Fibroblast growth factor; MSC: Mesenchymal stem cell; PDGF: Platelet-derived growth factor; TM:
Tympanic membrane; TMP: Tympanic membrane perforation.
harvested chondrocytes from the auricular cartilage and created a used for nose restoration in five patients. The patients did not report
gelatinous chondroid matrix, which was then injected into the nasal any complications in the subsequent twelve months and were
dorsa of 75 patients [50]. The gel hardened to form a neo-cartilage pleased with the aesthetics and functionality of the reconstructed
within a few weeks, and the cartilages were still functional after nose [51]. In 2018, Zhou et al. designed a specific scaffold based
6 years. Autologous nasal septal chondrocytes were used in human on a healthy ear for auricular reconstruction in five patients. The
exploratory trials in 2014 for nasal alar reconstruction. The cells scaffold was composed of biodegradable polymers cultivated with
were cultivated on collagen membranes for 4 weeks before being autologous chondrocytes. The results were satisfactory, and the
DOI: https://doi.org/10.36922/jctr.22.00151

