Clinical trial NCT04626583 - References

Safety — Safety of Locally Delivered Allogeneic Mesenchymal Stromal Cells

Citation(s)

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  Mesenchymal stromal cell injection promotes vocal fold scar repair without long-term engraftment. Cytotherapy. 2016 Oct;18(10):1284-96. doi: 10.1016/j.jcyt.2016.07.005.
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•   Cejkova J, Trosan P, Cejka C, Lencova A, Zajicova A, Javorkova E, Kubinova S, Sykova E, Holan V
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•   Cockerham GC, Lemke S, Glynn-Milley C, Zumhagen L, Cockerham KP
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•   Cockerham GC, Lemke S, Rice TA, Wang G, Glynn-Milley C, Zumhagen L, Cockerham KP
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•   Cockerham GC, Rice TA, Hewes EH, Cockerham KP, Lemke S, Wang G, Lin RC, Glynn-Milley C, Zumhagen L
  Closed-eye ocular injuries in the Iraq and Afghanistan wars. N Engl J Med. 2011 Jun 2;364(22):2172-3. doi: 10.1056/NEJMc1010683. No abstract available.
•   Cook N, Hansen AR, Siu LL, Abdul Razak AR
  Early phase clinical trials to identify optimal dosing and safety. Mol Oncol. 2015 May;9(5):997-1007. doi: 10.1016/j.molonc.2014.07.025. Epub 2014 Aug 14.
•   Elflein HM, Hofherr T, Berisha-Ramadani F, Weyer V, Lampe C, Beck M, Pitz S
  Measuring corneal clouding in patients suffering from mucopolysaccharidosis with the Pentacam densitometry programme. Br J Ophthalmol. 2013 Jul;97(7):829-33. doi: 10.1136/bjophthalmol-2012-302913. Epub 2013 May 17.
•   Enders P, Holtick U, Schaub F, Tuchscherer A, Hermann MM, Scheid C, Cursiefen C, Bachmann BO
  Corneal Densitometry for Quantification of Corneal Deposits in Monoclonal Gammopathies. Cornea. 2017 Apr;36(4):470-475. doi: 10.1097/ICO.0000000000001078.
•   Eslani M, Baradaran-Rafii A, Movahedan A, Djalilian AR
  The ocular surface chemical burns. J Ophthalmol. 2014;2014:196827. doi: 10.1155/2014/196827. Epub 2014 Jul 1.
•   Ghazaryan E, Zhang Y, He Y, Liu X, Li Y, Xie J, Su G
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•   Greenstein SA, Fry KL, Bhatt J, Hersh PS
  Natural history of corneal haze after collagen crosslinking for keratoconus and corneal ectasia: Scheimpflug and biomicroscopic analysis. J Cataract Refract Surg. 2010 Dec;36(12):2105-14. doi: 10.1016/j.jcrs.2010.06.067.
•   Gutierrez R, Lopez I, Villa-Collar C, Gonzalez-Meijome JM
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  Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee. Clin Cancer Res. 2010 Mar 15;16(6):1726-36. doi: 10.1158/1078-0432.CCR-09-1961. Epub 2010 Mar 9.
•   Kim BZ, Jordan CA, McGhee CN, Patel DV
  Natural history of corneal haze after corneal collagen crosslinking in keratoconus using Scheimpflug analysis. J Cataract Refract Surg. 2016 Jul;42(7):1053-9. doi: 10.1016/j.jcrs.2016.04.019.
•   Li F, Zhao SZ
  Control of Cross Talk between Angiogenesis and Inflammation by Mesenchymal Stem Cells for the Treatment of Ocular Surface Diseases. Stem Cells Int. 2016;2016:7961816. doi: 10.1155/2016/7961816. Epub 2016 Mar 24.
•   Ma Y, Xu Y, Xiao Z, Yang W, Zhang C, Song E, Du Y, Li L
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•   McLaren JW, Wacker K, Kane KM, Patel SV
  Measuring Corneal Haze by Using Scheimpflug Photography and Confocal Microscopy. Invest Ophthalmol Vis Sci. 2016 Jan 1;57(1):227-35. doi: 10.1167/iovs.15-17657.
•   Mittal SK, Omoto M, Amouzegar A, Sahu A, Rezazadeh A, Katikireddy KR, Shah DI, Sahu SK, Chauhan SK
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•   Oh JY, Kim MK, Shin MS, Lee HJ, Ko JH, Wee WR, Lee JH
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•   Pahuja N, Shetty R, Subbiah P, Nagaraja H, Nuijts RM, Jayadev C
  Corneal Densitometry: Repeatability in Eyes With Keratoconus and Postcollagen Cross-Linking. Cornea. 2016 Jun;35(6):833-7. doi: 10.1097/ICO.0000000000000800.
•   Prockop DJ, Oh JY
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•   Roddy GW, Oh JY, Lee RH, Bartosh TJ, Ylostalo J, Coble K, Rosa RH Jr, Prockop DJ
  Action at a distance: systemically administered adult stem/progenitor cells (MSCs) reduce inflammatory damage to the cornea without engraftment and primarily by secretion of TNF-alpha stimulated gene/protein 6. Stem Cells. 2011 Oct;29(10):1572-9. doi: 10.1002/stem.708.
•   Sacchetti M, Lambiase A
  Diagnosis and management of neurotrophic keratitis. Clin Ophthalmol. 2014 Mar 19;8:571-9. doi: 10.2147/OPTH.S45921. eCollection 2014.
•   Semeraro F, Forbice E, Romano V, Angi M, Romano MR, Filippelli ME, Di Iorio R, Costagliola C
  Neurotrophic keratitis. Ophthalmologica. 2014;231(4):191-7. doi: 10.1159/000354380. Epub 2013 Oct 2.
•   Stevens S
  Administering a subconjunctival injection. Community Eye Health. 2009 Mar;22(69):15. No abstract available.
•   Wang LT, Ting CH, Yen ML, Liu KJ, Sytwu HK, Wu KK, Yen BL
  Human mesenchymal stem cells (MSCs) for treatment towards immune- and inflammation-mediated diseases: review of current clinical trials. J Biomed Sci. 2016 Nov 4;23(1):76. doi: 10.1186/s12929-016-0289-5.
•   Weiner X, Baumeister M, Kohnen T, Buhren J
  Repeatability of lens densitometry using Scheimpflug imaging. J Cataract Refract Surg. 2014 May;40(5):756-63. doi: 10.1016/j.jcrs.2013.10.039.
•   Yao L, Li ZR, Su WR, Li YP, Lin ML, Zhang WX, Liu Y, Wan Q, Liang D
  Role of mesenchymal stem cells on cornea wound healing induced by acute alkali burn. PLoS One. 2012;7(2):e30842. doi: 10.1371/journal.pone.0030842. Epub 2012 Feb 17.
•   Ye J, Yao K, Kim JC
  Mesenchymal stem cell transplantation in a rabbit corneal alkali burn model: engraftment and involvement in wound healing. Eye (Lond). 2006 Apr;20(4):482-90. doi: 10.1038/sj.eye.6701913.
•   Yun YI, Park SY, Lee HJ, Ko JH, Kim MK, Wee WR, Reger RL, Gregory CA, Choi H, Fulcher SF, Prockop DJ, Oh JY
  Comparison of the anti-inflammatory effects of induced pluripotent stem cell-derived and bone marrow-derived mesenchymal stromal cells in a murine model of corneal injury. Cytotherapy. 2017 Jan;19(1):28-35. doi: 10.1016/j.jcyt.2016.10.007. Epub 2016 Nov 10.

Safety of Locally Delivered Allogeneic Mesenchymal Stromal Cells for Promoting Corneal Repair

Details for clinical trial NCT04626583