An Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS

STUDY OBJECTIVES:
Primary Objective: Assessment of treatment safety based on incidence of any treatment emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months post treatment.
Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3 months, 6 months and 12 months after treatment based on the following: EDSS and 29-item Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1) Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and gadolinium-enhanced magnetic resonance imaging (MRI).

Start Date01 Feb 2015

Sponsor / Collaborator

Novo Cellular Medicine Institute LLP

100 Clinical Results associated with Autologous Bone Marrow-Derived Mononuclear Stem Cells(Novo Cellular Medicine Institute LLP)

100 Translational Medicine associated with Autologous Bone Marrow-Derived Mononuclear Stem Cells(Novo Cellular Medicine Institute LLP)

100 Patents (Medical) associated with Autologous Bone Marrow-Derived Mononuclear Stem Cells(Novo Cellular Medicine Institute LLP)

Literatures (Medical) associated with Autologous Bone Marrow-Derived Mononuclear Stem Cells(Novo Cellular Medicine Institute LLP)

01 Aug 2013·Clinical CardiologyQ3 · MEDICINE

Combined Delivery of Bone Marrow‐Derived Mononuclear Cells in Chronic Ischemic Heart Disease: Rationale and Study Design

Q3 · MEDICINE

ArticleOA

Author: Soncin, Sabrina ; Cicero, Viviana Lo ; Sürder, Daniel ; Turchetto, Lucia ; Auricchio, Angelo ; Moccetti, Tiziano ; Radrizzani, Marina ; Muzzarelli, Stefano

AbstractBackgroundTreatment with bone marrow‐derived mononuclear cells (BM‐MNC) may improve left ventricular (LV) function in patients with chronic ischemic heart disease (IHD). Delivery method of the cell product may be crucial for efficacy.HypothesisWe aimed to demonstrate that the combination of intramyocardial and intracoronary injection of BM‐MNC is safe and improves LV function in patients with chronic IHD.MethodsAfter a safety/feasibility phase of 10 patients, 54 patients will be randomly assigned in a 1:1:1 pattern to 1 control and 2 BM‐MNC treatment groups. The control group will be treated with state‐of‐the‐art medical management. The treatment groups will receive either exclusively intramyocardial injection or a combination of intramyocardial and intracoronary injection of autologous BM‐MNC. Left ventricular function as well as scar size, transmural extension, and regional wall‐motion score will be assessed by cardiac magnetic resonance imaging studies at baseline and after 6 months. The primary endpoint is the change in global LV ejection fraction by cardiac magnetic resonance from 6 months to baseline.ResultsThe results, it is hoped, will have important clinical impact and provide essential information to improve the design of future regenerative‐medicine protocols in cardiology.ConclusionsAs cell delivery may play an important role in chronic IHD, we aim to demonstrate feasibility and efficacy of a combined cell‐delivery approach in patients with decreased LV function.

01 Aug 2007·European Journal of Heart FailureQ1 · MEDICINE

Paracrine effects of direct intramyocardial implantation of bone marrow derived cells to enhance neovascularization in chronic ischaemic myocardium

Q1 · MEDICINE

Article

Author: Zhang, Qing‐Yong ; Songyan, Liao ; Lau, Chu‐Pak ; Tse, Hung‐Fat ; Siu, Chung‐Wah ; Nicholls, John ; Kwong, Yok‐Lam ; Lai, Wing‐Hon ; Zhu, Shu‐Guang

AbstractObjectiveTo determine the optimal bone marrow (BM) cell types, and their potential mechanisms of action for neovascularization in chronic ischaemic myocardium.Methods and resultsThe functional effects, angiogenic potential and cytokine expression of direct intramyocardial implantation of autologous BM CD31‐positive endothelial progenitor cells (EPC, n=9), BM mononuclear cells (MNCs, n=9), and saline (n=9) were compared in a swine model of chronic ischaemic myocardium. Autologous BM cells were harvested and catheter‐based electromechanical mapping‐guided direct intramyocardial injection was performed to target ischaemic myocardium. After 12 weeks, injection of BM‐MNC resulted in significant improvements in left ventricular dP/dt (+21±8%, P=0.032), left ventricular pressure (+17±4%, P=0.048) and regional microsphere myocardial perfusion over ischaemic endocardium (+74±28%, P<0.05) and epicardium (+73±29%, P<0.05). No significant effects were observed following injection of BM‐EPC or saline. Capillary density (1132±69 versus 903±44 per mm2, P=0.047) and expression of mRNA of vascular endothelial growth factor (VEGF, 32.3±5.6 versus 13.1±3.7, P<0.05,) and angiopoietin‐2 (23.9±3.6 versus 13.7±3.1, P<0.05) in ischaemic myocardium was significantly greater in the BM‐MNC group than the saline group. The capillary density in ischaemic myocardium demonstrated a significant positive correlation with VEGF expression (r=0.61, P<0.001).ConclusionCatheter‐based direct intramyocardial injection of BM‐MNC enhanced angiogenesis more effectively than BM‐EPC or saline, possibly via a paracrine effect, with increased expression of VEGF that subsequently improved cardiac performance of ischaemic myocardium.

100 Deals associated with Autologous Bone Marrow-Derived Mononuclear Stem Cells(Novo Cellular Medicine Institute LLP)

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