Efficacy and Safety of Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Patients with Diabetic Retinopathy

Abstract

Background/Aims: The treatment options for diabetic retinopathy (DR) are limited. Mesenchymal stem cells (MSCs) are a promising treatment option for diabetes and its complications. In this pilot clinical trial, we evaluated the safety and efficacy of intravenous autologous bone marrow MSCs (ABMSC) for the treatment of DR. Methods: In total, 34 eyes with non-proliferative or proliferative DR (NPDR, n = 19; PDR, n = 15) from 17 patients were analyzed. Treatment involved one intravenous infusion of 3 × 10⁶/kg ABSMCs. The patients’ vital signs were monitored, along with immune and allergic reactions. Treatment efficacy was evaluated via measurements of the following parameters at baseline, and at 1, 3, and 6 months after treatment: the levels of fasting blood glucose (FBG), Hemoglobin A1C (HbA_1C), interleukin-6 (IL-6), and hypersensitive C-reactive protein (CRP); best corrected visual acuity (BCVA); and central macular and subfield thickness (via optical computed tomography). Results: ABMSC infusion led to a significant decrease in FBG and CRP levels (P < 0.05). There were no significant differences in HbA_1C or IL-6 levels. Sub-group analysis revealed that only eyes in the NPDR group had the macular thickness reductions and a significant improvement in BCVA from baseline (P = 0.006 at 3 months and 0.027 at 6 months), while those in the PDR group did not. There were no acute reactions during the treatment or severe adverse events during the follow-up period. Conclusion: ABSMCs are a potentially safe and effective treatment option for DR, and the optimum therapeutic window appears to be during the NPDR stage.

Off-the-shelf mesenchymal stem cells from human umbilical cord tissue can significantly improve symptoms in COVID-19 patients: An analysis of evidential relations

“…In the report by Leng et al[ 38 ] (2020), the levels of CRP and TNF-α were both reduced in treated COVID-19 patients. These observations are similar to those previously published on MSC transplantation for immunological diseases[ 52 , 53 ]. MSCs also inhibit the maturation of T cells and prevent them from becoming too active[ 54 , 55 ].…”

A Review on Mesenchymal Stem Cells for Treatment of Retinal Diseases

“…During 6 months follow-up, the patients of the NPDR group exhibited significant gain in BCVA (best corrected visual acuity) (P=0.006 at 3 months and P=0.027 at 6 months) and macular thickness reductions. On the contrary, only a slight BCVA improvement and macular thickening was recorded in the PDR group suggesting that the treatment regime is suitable for patients at NPDR stage, rather than PDR stage [180].…”

Interaction Between Mesenchymal Stem Cells and Retinal Degenerative Microenvironment

“…Interestingly, intravitreally injected BM-MSCs were found to integrate into the inner retina, differentiate into retinal glial cells, and improve ERG amplitude, thereby protecting vision in a STZ-induced mouse model (Çerman et al, 2016). Excitingly, intravenously administrated autologous BM-MSCs were found to be beneficial in non-proliferative DR (NPDR) patients, showing significant improvements in macular thickness and best-corrected visual acuity (BCVA) from baseline (Gu et al, 2018).…”