scholarly journals Safety and Efficacy of 2 Intracavernous Injections of Allogeneic Wharton’s Jelly-Derived Mesenchymal Stem Cells in Diabetic Patients with Erectile Dysfunction: Phase 1/2 Clinical Trial

2021 ◽  
pp. 1-9
Author(s):  
Saddam Al Demour ◽  
Sofia Adwan ◽  
Hanan Jafar ◽  
Reem Rahmeh ◽  
Hussam Alhawari ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Erectile Dysfunction ◽  
Phase 1 ◽  
Wharton’S Jelly ◽  
Secondary Outcome ◽  
Diabetic Patients ◽  
Safety And Efficacy ◽  
Wharton's Jelly

<b><i>Background and Objectives:</i></b> Stem cell therapy is a novel treatment with regenerative ability that can treat erectile dysfunction (ED). This phase 1/2 clinical trial (NCT02945449) using 2 consecutive intracavernous (IC) injections of allogeneic Wharton’s jelly-derived mesenchymal stem cells (WJ-MSCs) was studied for the first time in the treatment of diabetic patients with ED. The primary outcome was to assess the safety and tolerability, and the secondary outcome was to assess the efficacy of 2 consecutive IC injections of allogeneic WJ-MSCs in diabetic ED. <b><i>Patients and Methods:</i></b> Twenty-two diabetic patients with refractory ED were included. Two consecutive IC injections of allogeneic WJ-MSCs were performed. Tolerability was assessed immediately, and at 24 h, safety was evaluated for 12 months. Efficacy was assessed using International Index of Erectile Function-5 (IIEF-5), Erection Hardness Score (EHS), and Color Duplex Doppler Ultrasound for 12 months. <b><i>Results:</i></b> The procedure was well-tolerated. Minimal and transient adverse events were redness and bruising at the site of injections. There were no patient-reported serious adverse effects. There were significant improvements in IIEF-5, EHS, peak systolic velocity (PSV) basal, and 20-min PSV, all over the follow-up time points in comparison to the baseline. <b><i>Conclusion:</i></b> This is the first human study with proven tolerability, safety, and efficacy of IC injections of allogeneic WJ-MSCs for the treatment of diabetic patients with ED.

scholarly journals Cell therapy in patients with COVID-19 using Wharton’s jelly mesenchymal stem cells: a phase 1 clinical trial

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Mahshid Saleh ◽  
Amir Abbas Vaezi ◽  
Rasoul Aliannejad ◽  
Amir Ali Sohrabpour ◽  
Seyedeh Zahra Fotook Kiaei ◽  
...  
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Cell Therapy ◽  
Phase 1 ◽  
Wharton’S Jelly ◽  
Biochemical Tests ◽  
Intravenous Injections ◽  
Wharton's Jelly ◽  
Inflammatory Phase ◽  
Before And After

Abstract Background Mesenchymal stem cells (MSCs) have received particular attention because of their ability to modulate the immune system and inhibit inflammation caused by cytokine storms due to SARS-CoV-2. New alternative therapies may reduce mortality rates in patients with COVID19. This study aimed to assess the safety and efficacy of injecting intravenous Wharton’s jelly-derived MSCs in patients with COVID-19 as a treatment. Methods In this study, five patients with severe COVID-19 were treated with Wharton’s jelly-derived mesenchymal stem cells (150 × 106 cells per injection). These patients were subject to three intravenous injections 3 days apart, and monitoring was done on days 0, 3, 6, and 14 in routine tests, inflammatory cytokines, and flow cytometry of CD4 and CD8 markers. A lung CT scan was performed on base and days 14 and 28. In addition, IgM and IgG antibodies against SARS-CoV-2 were measured before and after treatment. Results The results showed that IL-10 and SDF-1 increased after cell therapy, but VEGF, TGF-β, IFN-γ, IL-6, and TNFα decreased. Routine hematology tests, myocardial enzyme tests, biochemical tests, and inflammation tests were performed for all patients before and after cell therapy on base and days 3, 6, and 14, which indicated the improvement of test results over time. COVID-19 antibody tests rose in 14 days after WJ-MSC injection. The total score of zonal involvement in both lungs was improved. Conclusions In patients, the trend of tests was generally improving, and we experienced a reduction in inflammation. No serious complications were observed in patients except the headache in one of them, which was resolved without medication. In this study, we found that patients with severe COVID-19 in the inflammatory phase respond better to cell therapy. More extensive clinical trials should be performed in this regard. Trial registration IRCT, IRCT20190717044241N2. Registered April 22, 2020.

scholarly journals Safety and Efficacy of Human Wharton's Jelly-Derived Mesenchymal Stem Cells Therapy for Retinal Degeneration

PLoS ONE ◽  
2015 ◽  
Vol 10 (6) ◽  
pp. e0128973 ◽  
Author(s):  
S. N. Leow ◽  
Chi D. Luu ◽  
M. H. Hairul Nizam ◽  
P. L. Mok ◽  
R. Ruhaslizan ◽  
...  
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Retinal Degeneration ◽  
Wharton’S Jelly ◽  
Safety And Efficacy ◽  
Wharton's Jelly ◽  
Stem Cells Therapy

Identify the role of Human Wharton's Jelly Mesenchymal Stem Cells in repairing injured uterine of rat

2021 ◽  
Vol 47 (1) ◽  
pp. 320-328
Author(s):  
Hezhu Wang ◽  
Xiaoqing Yang ◽  
Xiaojing Chen ◽  
Huihui Xie ◽  
Junxia Wang ◽  
...  
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Wharton’S Jelly ◽  
Wharton's Jelly

scholarly journals Exosomes derived from human umbilical cord Wharton's jelly mesenchymal stem cells ameliorate experimental lymphedema

2021 ◽  
Vol 11 (7) ◽  
Author(s):  
Zhao Ting ◽  
Yan Zhi‐xin ◽  
Tan You‐wen ◽  
Yang Fu‐ji ◽  
Sun Hui ◽  
...  
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Umbilical Cord ◽  
Wharton’S Jelly ◽  
Human Umbilical Cord ◽  
Wharton's Jelly
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