This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research
Zhengqin Yin
Third Military Medical University: Army Medical University
Corresponding Author
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Background: Retinitis pigmentosa (RP) is a hereditary retinal degenerative disease leading to eventual blindness. Macular edema (ME) is a frequent complication in RP. When RP is combined with ME, the visual impairment further worsens. Well controlled ME is crucial to prevent RP from advancing. We compared the intravenous infusion of umbilical cord mesenchymal stem cells (UCMSCs) and a modified sub-Tenon’s capsule injection of triamcinolone acetonide (TA) in the treatment of RP combined with ME to assess their safety and efficacy in eliminating macular edema.
Methods: A phase I/II clinical trial enrolled 20 patients was conducted. Patients in the UCMSCs infusion group received a single intravenous infusion of 3 × 106 UCMSCs, and patients in the TA injection group received a modified sub-Tenon’s capsule injection of 20 mg of TA. All patients were followed up for 6 months. Systemic and ophthalmological investigations were performed to assess the safety and efficacy.
Results: There were no severe adverse effects in both groups. At 2nd month follow up, the thickness of the central fovea in TA injection group was significantly lower than that in UCMSCs infusion group (P<0.05). The gradient of decrease of average macular thickness in TA injection group was significantly higher than that in UCMSCs group (P<0.05). At 6th month follow up, the central fovea thickness was higher in the TA injection group than that in UCMSCs infusion group (P<0.05). The average amplitude/latency (A/L) of the P2 wave in the flash visual evoked potential (FVEP) in UCMSCs infusion group was significantly higher at 6th month follow up than that in TA injection group (P<0.05).
Conclusions: This study suggests TA injection is more effective at reducing ME in a short term. UCMSC intravenous infusion exerts slow but persistent action in reducing ME, and can maintain the visual function for a longer time. These approaches can be applied separately or jointly depending on the disease condition for patients to benefit maximumly.
Trial registration: chictr.org.cn: ChiCTR-ONC-16008839. Registered on July 14, 2016.
Keywords
Umbilical Cord Mesenchymal Stem Cells, Triamcinolone Acetonide, Retinitis Pigmentosa, Macular Edema, Sub-Tenon’s Capsule Injection
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This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research
Zhengqin Yin
Third Military Medical University: Army Medical University
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 09 Jan, 2021
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Retinitis pigmentosa (RP) is a hereditary retinal degenerative disease leading to eventual blindness. Macular edema (ME) is a frequent complication in RP. When RP is combined with ME, the visual impairment further worsens. Well controlled ME is crucial to prevent RP from advancing. We compared the intravenous infusion of umbilical cord mesenchymal stem cells (UCMSCs) and a modified sub-Tenon’s capsule injection of triamcinolone acetonide (TA) in the treatment of RP combined with ME to assess their safety and efficacy in eliminating macular edema.
Methods: A phase I/II clinical trial enrolled 20 patients was conducted. Patients in the UCMSCs infusion group received a single intravenous infusion of 3 × 106 UCMSCs, and patients in the TA injection group received a modified sub-Tenon’s capsule injection of 20 mg of TA. All patients were followed up for 6 months. Systemic and ophthalmological investigations were performed to assess the safety and efficacy.
Results: There were no severe adverse effects in both groups. At 2nd month follow up, the thickness of the central fovea in TA injection group was significantly lower than that in UCMSCs infusion group (P<0.05). The gradient of decrease of average macular thickness in TA injection group was significantly higher than that in UCMSCs group (P<0.05). At 6th month follow up, the central fovea thickness was higher in the TA injection group than that in UCMSCs infusion group (P<0.05). The average amplitude/latency (A/L) of the P2 wave in the flash visual evoked potential (FVEP) in UCMSCs infusion group was significantly higher at 6th month follow up than that in TA injection group (P<0.05).
Conclusions: This study suggests TA injection is more effective at reducing ME in a short term. UCMSC intravenous infusion exerts slow but persistent action in reducing ME, and can maintain the visual function for a longer time. These approaches can be applied separately or jointly depending on the disease condition for patients to benefit maximumly.
Trial registration: chictr.org.cn: ChiCTR-ONC-16008839. Registered on July 14, 2016.
Figure 1
Figure 2
Figure 3
This is a list of supplementary files associated with this preprint. Click to download.
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