Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
NCT ID: NCT05204329
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
9 participants
INTERVENTIONAL
2024-01-24
2024-11-08
Brief Summary
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Detailed Description
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1. Incidence of treatment emergent adverse events (TEAE) assessed at 28 days following treatment initiation
2. Proportion of patients with improved corneal epithelial barrier at 28 days compared to baseline
3. Final visual acuity, corneal epithelial thickness, corneal stromal haze, corneal sensation, and treatment tolerability
The objective is to determine the dose of MSC Secretome through a first-in-human study through a dose-escalation strategy targeting a toxicity rate of 33% or less.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Low dose of allogenic MSC drops
Escalating doses of allogenic MSC eye drops will be assigned at the lowest dose level.
MSC Secretome Eye Drops
MSC Secretome eye drop will be dispensed.
Medium dose of allogenic MSC drops
Escalating doses of allogenic MSC eye drops will be assigned at the medium dose level.
MSC Secretome Eye Drops
MSC Secretome eye drop will be dispensed.
High dose of allogenic MSC drops
Escalating doses of allogenic MSC eye drops will be assigned at the high dose level.
MSC Secretome Eye Drops
MSC Secretome eye drop will be dispensed.
Interventions
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MSC Secretome Eye Drops
MSC Secretome eye drop will be dispensed.
Eligibility Criteria
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Inclusion Criteria
* Chronic corneal epithelial disease with fluorescein staining score ≥ 6 by NEI grading scale
* Reduced corneal sensation (≤ 4 cm measured by Cochet Bonnet esthesiometry) in at least one corneal quadrant
* A stable ocular surface with no objective clinical evidence of significant (\> 50%) improvement/worsening of the epithelial disease in the last 30 days
* Epithelial disease refractory to conventional non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy)
Exclusion Criteria
* Evidence of corneal ulceration with stromal loss \> 10%
* Presence of an epithelial defect ≥1.0 mm in the largest diameter in the affected eye
* Presence of any size epithelial defect that has been persistent for more than 30 days
* Patients unable to discontinue or intermittently remove therapeutic contact lens in the study eye (to apply drops) during the 4-week study period
* History of any ocular surgery (including laser or refractive surgical procedures) in the affected eye within the 3 months prior to study enrollment
* History of chemical injury within the last 6 months prior to study enrollment Known hypersensitivity to one of the components of the study or procedural medications (e.g.,fluorescein)
* History of drug, medication or alcohol abuse or addiction
* Use of any investigational agent within 4 weeks of screening visit
* History of previous enrollment in the MSC Secretome Study at a lower dose
* Participation in another clinical study at the same time as the present study
* Participants who are pregnant at the time of study enrollment
18 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
National Institutes of Health (NIH)
NIH
University of Illinois at Chicago
OTHER
Responsible Party
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Ali R Djalilian
Professor of Ophthalmology
Principal Investigators
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Ali R Djalilian, MD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Charlotte E Joslin, OD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Elmer Y Tu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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University of Illinois at Chicago
Chicago, Illinois, United States
Countries
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References
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Prockop DJ, Oh JY. Mesenchymal stem/stromal cells (MSCs): role as guardians of inflammation. Mol Ther. 2012 Jan;20(1):14-20. doi: 10.1038/mt.2011.211. Epub 2011 Oct 18.
Mittal SK, Omoto M, Amouzegar A, Sahu A, Rezazadeh A, Katikireddy KR, Shah DI, Sahu SK, Chauhan SK. Restoration of Corneal Transparency by Mesenchymal Stem Cells. Stem Cell Reports. 2016 Oct 11;7(4):583-590. doi: 10.1016/j.stemcr.2016.09.001. Epub 2016 Sep 29.
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.
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.
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.
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.
Oh JY, Kim MK, Shin MS, Lee HJ, Ko JH, Wee WR, Lee JH. The anti-inflammatory and anti-angiogenic role of mesenchymal stem cells in corneal wound healing following chemical injury. Stem Cells. 2008 Apr;26(4):1047-55. doi: 10.1634/stemcells.2007-0737. Epub 2008 Jan 10.
Ma Y, Xu Y, Xiao Z, Yang W, Zhang C, Song E, Du Y, Li L. Reconstruction of chemically burned rat corneal surface by bone marrow-derived human mesenchymal stem cells. Stem Cells. 2006 Feb;24(2):315-21. doi: 10.1634/stemcells.2005-0046. Epub 2005 Aug 18.
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.
Cejkova J, Trosan P, Cejka C, Lencova A, Zajicova A, Javorkova E, Kubinova S, Sykova E, Holan V. Suppression of alkali-induced oxidative injury in the cornea by mesenchymal stem cells growing on nanofiber scaffolds and transferred onto the damaged corneal surface. Exp Eye Res. 2013 Nov;116:312-23. doi: 10.1016/j.exer.2013.10.002. Epub 2013 Oct 18.
Eslani M, Putra I, Shen X, Hamouie J, Afsharkhamseh N, Besharat S, Rosenblatt MI, Dana R, Hematti P, Djalilian AR. Corneal Mesenchymal Stromal Cells Are Directly Antiangiogenic via PEDF and sFLT-1. Invest Ophthalmol Vis Sci. 2017 Oct 1;58(12):5507-5517. doi: 10.1167/iovs.17-22680.
Uccelli A, de Rosbo NK. The immunomodulatory function of mesenchymal stem cells: mode of action and pathways. Ann N Y Acad Sci. 2015 Sep;1351:114-26. doi: 10.1111/nyas.12815. Epub 2015 Jul 6.
Coulson-Thomas VJ, Coulson-Thomas YM, Gesteira TF, Kao WW. Extrinsic and Intrinsic Mechanisms by Which Mesenchymal Stem Cells Suppress the Immune System. Ocul Surf. 2016 Apr;14(2):121-34. doi: 10.1016/j.jtos.2015.11.004. Epub 2016 Jan 12.
Maguire G. Stem cell therapy without the cells. Commun Integr Biol. 2013 Nov 1;6(6):e26631. doi: 10.4161/cib.26631. Epub 2013 Sep 27.
Madrigal M, Rao KS, Riordan NH. A review of therapeutic effects of mesenchymal stem cell secretions and induction of secretory modification by different culture methods. J Transl Med. 2014 Oct 11;12:260. doi: 10.1186/s12967-014-0260-8.
Fernandes-Cunha GM, Na KS, Putra I, Lee HJ, Hull S, Cheng YC, Blanco IJ, Eslani M, Djalilian AR, Myung D. Corneal Wound Healing Effects of Mesenchymal Stem Cell Secretome Delivered Within a Viscoelastic Gel Carrier. Stem Cells Transl Med. 2019 May;8(5):478-489. doi: 10.1002/sctm.18-0178. Epub 2019 Jan 15.
Eslani M, Putra I, Shen X, Hamouie J, Tadepalli A, Anwar KN, Kink JA, Ghassemi S, Agnihotri G, Reshetylo S, Mashaghi A, Dana R, Hematti P, Djalilian AR. Cornea-Derived Mesenchymal Stromal Cells Therapeutically Modulate Macrophage Immunophenotype and Angiogenic Function. Stem Cells. 2018 May;36(5):775-784. doi: 10.1002/stem.2781. Epub 2018 Jan 27.
Samaeekia R, Rabiee B, Putra I, Shen X, Park YJ, Hematti P, Eslani M, Djalilian AR. Effect of Human Corneal Mesenchymal Stromal Cell-derived Exosomes on Corneal Epithelial Wound Healing. Invest Ophthalmol Vis Sci. 2018 Oct 1;59(12):5194-5200. doi: 10.1167/iovs.18-24803.
Vizoso FJ, Eiro N, Cid S, Schneider J, Perez-Fernandez R. Mesenchymal Stem Cell Secretome: Toward Cell-Free Therapeutic Strategies in Regenerative Medicine. Int J Mol Sci. 2017 Aug 25;18(9):1852. doi: 10.3390/ijms18091852.
Bara JJ, Richards RG, Alini M, Stoddart MJ. Concise review: Bone marrow-derived mesenchymal stem cells change phenotype following in vitro culture: implications for basic research and the clinic. Stem Cells. 2014 Jul;32(7):1713-23. doi: 10.1002/stem.1649.
Ivy SP, Siu LL, Garrett-Mayer E, Rubinstein L. 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.
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.
Related Links
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U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products.
Other Identifiers
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2021-0754
Identifier Type: -
Identifier Source: org_study_id