Preliminary Safety of Intracranial Implantation of Modified Bone Marrow Mesenchymal Stem Cells (SB623) in Stroke Patients: A Phase 1/2A Study

2016 ◽  
Vol 97 (12) ◽  
pp. e2 ◽  
Author(s):  
Gary Steinberg ◽  
Wenzhong Jerry Liu ◽  
Damien Bates ◽  
Douglas Kondziolka ◽  
Lawrence Wechsler ◽  
...  
2017 ◽  
Vol 11 (1) ◽  
pp. 74-83 ◽  
Author(s):  
Asra Al Fauzi ◽  
Purwati Sumorejo ◽  
Nur Setiawan Suroto ◽  
Muhammad Arifin Parenrengi ◽  
Joni Wahyuhadi ◽  
...  

Object:Stroke, one of the most devastating diseases, is a leading cause of death and disability throughout the world and is also associated with emotional and economic problems. The main goal of this study was to investigate the clinical outcome of the intraventricular transplantation of bone marrow mesenchymal stem cells (BM-MSCs) in post-haemorrhagic stroke patients.Method:This study was done consisting of eight patients with supratentorial haemorrhagic stroke, who had undergone 24 weeks of standard treatment of stroke with stable neurological deficits. All of the patients received stem cell transplantation intraventricularly using autologous BM-MSCs. Six months and Twelve months after stem cells treatment, the clinical outcomes were measured using the National Institute of Health Stroke Scale (NIHSS) and adverse effect also observed.Result:The results of this study showed improvement of NIHSS score values before and after the treatment in five patients. No adverse effects or complications were detected during the 1-year observation.Conclusion:Intraventricular transplantation of BM-MSCs has shown benefits in improving the functional status of post-haemorrhagic stroke patients with no adverse effect.


2021 ◽  
pp. 036354652199872
Author(s):  
Gil Rodas ◽  
Robert Soler-Rich ◽  
Joan Rius-Tarruella ◽  
Xavier Alomar ◽  
Ramon Balius ◽  
...  

Background: Patellar tendinopathy is common. The success of traditional management, including isometric or eccentric exercises combined with shockwave therapy and even surgery, is limited. Therefore, it is important to determine whether biological treatments such as ultrasound-guided intratendinous and peritendinous injections of autologous expanded bone marrow mesenchymal stem cells (BM-MSCs) or leukocyte-poor platelet-rich plasma (Lp-PRP) improve clinical outcomes in athletic patients with patellar tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A prospective, double-blinded, randomized, 2-arm parallel group, active controlled, phase 1/2 single-center clinical study was performed in patients who had proximal patellar tendinopathy with a lesion >3 mm. A total of 20 participants (age 18-48 years) with pain for >4 months (mean, 23.6 months) and unresponsive to nonoperative treatments were randomized into 2 groups. Of these, 10 participants were treated with BM-MSC (20 × 106 cells) and 10 with Lp-PRP. Both groups performed the same postintervention rehabilitation protocol. Outcomes included the Victorian Institute of Sport Assessment for pain (VISA-P), self-reported tendon pain during activity (visual analog scale [VAS]), muscle function by dynamometry, tendon thickness and intratendinous vascularity by ultrasonographic imaging and Doppler signal, ultrasound tissue characterization (UTC) echo type changes, and magnetic resonance imaging (MRI) T2-weighted mapping changes. Participants were followed longitudinally for 6 months. Results: The average VAS scores improved in both groups at all time points, and there was a significant reduction in pain during sporting activities ( P < .05). In both groups, the average mean VISA-P scores at 6 months were significantly increased compared with baseline (66 BM-MSC group and 72.90 Lp-PRP group), with no significant differences in VAS or VISA-P scores between the groups. There were statistically significant greater improvements in tendon structure on 2-dimensional ultrasound and UTC in the BM-MSC group compared with the Lp-PRP group at 6 months. Similarly, the BM-MSC group demonstrated significant evidence of restoration of tendon structure on MRI compared with the Lp-PRP group at 6 months. Only the participants in the BM-MSC group showed evidence of normalization of tendon structure, with statistically significant differences between the groups on T2-weighted, fat-saturated sagittal and coronal scans and hypersignal in T2-weighted on spin-echo T2-weighted coronal MRI scan. Both treatments were safe, and no significant adverse events were reported in either group. Conclusion: Treatment with BM-MSC or Lp-PRP in combination with rehabilitation in chronic patellar tendinopathy is effective in reducing pain and improving activity levels in active participants. Participants who received BM-MSC treatment demonstrated greater improvement in tendon structure compared with those who received Lp-PRP. Registration: 2016-001262-28 (EudraCT identifier); NCT03454737 (ClinicalTrials.gov identifier)


2013 ◽  
Author(s):  
Melo Ocarino Natalia de ◽  
Silvia Silva Santos ◽  
Lorena Rocha ◽  
Juneo Freitas ◽  
Reis Amanda Maria Sena ◽  
...  

2014 ◽  
Author(s):  
Reis Amanda Maria Sena ◽  
Freitas Silva Juneo de ◽  
Silvia Silva Santos ◽  
Rogeria Serakides ◽  
Melo Ocarino Natalia de

2013 ◽  
Vol 28 (3) ◽  
pp. 224-231
Author(s):  
Zhenhua REN ◽  
Jiayin WANG ◽  
Shuyan WANG ◽  
Ying ZHANG ◽  
Chunlin ZOU ◽  
...  

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