Objectives: This open label, phase I clinical trial (NCT02945462) using 2 consecutive intracavernous autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) for the first time in the treatment of diabetic patients with erectile dysfunction (ED). The primary outcome is to assess the safety and tolerability of intracavernous autologous BM-MSCs, the secondary outcome is to assess efficacy of the procedure. Patients and Methods: Four diabetic patients with refractory ED were included. Two consecutive intracavernous autologous BM-MSC injections were performed. Tolerability was assessed immediately and at 24 h, safety was evaluated for 2 years. Efficacy was assessed using International Index of Erectile Function-15 (IIEF-15) and Erection Hardness Score (EHS) for 12 months. Results: procedure was well tolerated and no patients reported significant adverse effects. There was significant improvement of IIEF-15 and EHS; IIEF-15 (p = 0.04), Erectile Function (p = 0.03), Sexual Desire (p = 0.04), Intercourse Satisfaction (p = 0.04), and Overall Satisfaction (p = 0.04). Conclusion: This is the first human study with proven tolerability, safety and efficacy of intracavernous autologous BM-MSC injections for treatment of diabetic patients with ED.
Aim: To assess the degree of diabetic patients' awareness about diabetic retinopathy and their action toward having screening tests and follow up visits.Methods: Diabetic patients who attended the diabetes clinic at Jordan University Hospital were administered a questionnaire in order to assess their awareness of diabetic retinopathy and the need to do a routine screening and follow up care for this disease.Results: A total of 115 patients were included in the study. of the enrolled patients; 58 were males (50.4%). The vast majority of patients enrolled believed that; diabetes could affect their eyes (98.3%), controlling their blood sugar levels can help preserve their vision (98.3%), and that diabetes can lead to blindness (99.1%). However, only about half of the surveyed patients claimed to be familiar with diabetic retinopathy (50.4%). When asked if it was important for diabetics to have their eyes checked annually, the majority answered yes (90.4%). In contrast, less than half of the patients reported getting their eyes checked annually (38.3%). When asked about barriers preventing the patients from getting eye screening, lack of knowledge about diabetic retinopathy scored the highest (33.9%), in line with the relative lack of familiarity of these patients with diabetic retinopathy.
Conclusion:Although most of the subjects of this study knew that diabetes mellitus can affect the eye and that better control of diabetes mellitus can prevent or delay the onset of DR, there was significant discordance between that knowledge and having appropriate screening and management of DR. These findings emphasize the need for increasing the awareness of diabetic retinopathy amongst Jordanian diabetics and the importance of annual ophthalmic eye screening.
Purpose The association between autoimmune diseases and keratoconus (KC) has been proposed based on previous retrospective studies and case reports. The aim of our study is to investigate whether KC is associated with autoimmune thyroid disease. Methods. A comparative study was conducted on 131 adult subjects from September 2015 to May 2017 at Jordan University Hospital, Amman, Jordan. Subjects were classified into 2 groups: subjects with autoimmune thyroid disease, including Graves' disease and Hashimoto's thyroiditis (n = 68), and a healthy group for comparison (n = 63). Subjects with any other conditions known to be associated with KC were excluded. The diagnosis of KC was based on clinical and corneal topographic findings utilizing the Oculus-Pentacam machine. In addition, TSH and total T4 levels as well as thyroid peroxidase antibodies were measured in all study participants. Antithyroglobulin antibodies, thyroid stimulating immunoglobulin, thyroid ultrasound, and thyroid uptake and scan were also selectively performed in some participants. Results This study included a total of 131 participants (101 females and 30 males), including patients and controls. In the multivariate analysis, autoimmune disease was not significantly associated with keratoconus (OR = 1.1; 95% confidence interval: 0.3, 3.8; p value = 0.353) after adjusting for age and gender. Conclusion This study did not show a statistically significant association between autoimmune thyroid disease and KC.
<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.
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