Delving into the Latest Updates on Stem cells(Honya Medical) with Synapse

Overview

Basic Info

Drug Type

Stem cell therapy

Synonyms

MiSaver

Target-

Mechanism

Cell replacements

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Acute myocardial infarction

Inactive Indication-

Originator Organization

HONYA Medical Co., Ltd.

Active Organization

HONYA Medical Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. An open-label trial was initiated to assess the safety and feasibility of intravenous infusion of ABO blood group-matched allogeneic umbilical cord blood stem cells (USC) prefabricated into MiSaver (Myocardial Infarction Saver) in AMI patients.
Primary Endpoint:
The primary endpoint focused on safety and adverse events over a 12-month observational period. Results showed the treatment was well-tolerated with no AEs attributed to the study product.
Secondary Outcomes:
Secondary outcomes evaluated changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment. A retrospective study compared eligible controls with low and middle dosage groups.

Start Date01 Jan 2023

Sponsor / Collaborator

HONYA Medical Co., Ltd.

[+1]

NCT04050163 / CompletedPhase 1/2

Safety and Preliminary Efficacy Study of Intravenous Administration of MiSaver® (Myocardial Infarction Saver) After Acute Myocardial Infarction, a Phase I/IIa Clinical Trial.

The objective of the present study is to establish the safety and efficacy of MiSaver® Stem Cell Treatment After a Heart Attack (Acute Myocardial Infarction)

Start Date26 Jan 2021

Sponsor / Collaborator

HONYA Medical Co., Ltd.

[+1]

CTRI/2010/091/000270 / RecruitingNot Applicable

A Pilot Study on the Use of Allogenic Mesenchymal Stem Cells For Osteoarthritis

Start Date12 Mar 2010

Sponsor / Collaborator-

100 Clinical Results associated with Stem cells(Honya Medical)

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100 Translational Medicine associated with Stem cells(Honya Medical)

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100 Patents (Medical) associated with Stem cells(Honya Medical)

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2

Literatures (Medical) associated with Stem cells(Honya Medical)

01 Dec 2016·The Journal of Thoracic and Cardiovascular SurgeryQ1 · MEDICINE

The IMPACT-CABG trial: A multicenter, randomized clinical trial of CD133+ stem cell therapy during coronary artery bypass grafting for ischemic cardiomyopathy

Q1 · MEDICINE

Article

Author: Denis Claude Roy ; Louis-Mathieu Stevens ; Ignacio Prieto ; Shu-Hong Li ; Andrew M. Crean ; Eric Larose ; Shant Der Sarkissian ; Katherine Tsang ; Samer Mansour ; Bernd Wintersperger ; Ren-Ke Li ; Minh Quan Vu ; Nicolas Noiseux ; Richard Weisel ; Terrence M. Yau

OBJECTIVESThe IMPACT-CABG trial is the first North American multicenter phase II randomized study of intramyocardial delivery of autologous CD133⁺ stem cells in patients with chronic ischemic cardiomyopathy undergoing coronary artery bypass grafting. The primary objective was to demonstrate safety, including freedom from major adverse cardiac events. The secondary objective was to evaluate feasibility of same-day autologous cell preparation. Although the trial was not powered to evaluate LV function, exploratory data were collected.METHODSAfter 7 open-label patients who received cells, patients randomly received stem cells or placebo (N = 40 total, 20 per center). After completion of coronary anastomoses, up to 10 million CD133⁺, CD34⁺, CD45⁺ triple-positive cells or placebo were injected into the infarct and border zones. Patients were followed up clinically and underwent magnetic resonance imaging preoperatively and after 6 months.RESULTSThere were no procedural complications from bone marrow isolation and cell injection, no in-hospital mortality, and no protocol-related complications. Four patients had transient renal insufficiency, with 1 death during 6-month follow-up. Magnetic resonance imaging revealed that left ventricular volumes and ejection fractions improved in all patients (no difference between groups).CONCLUSIONSThe trial successfully met both primary and secondary objectives, demonstrating that same-day isolation and autologous CD133⁺ cell delivery with coronary artery bypass grafting is safe and feasible. The positive findings support a larger randomized, multicenter trial, with higher numbers of transplanted cells to demonstrate beneficial effects. The upcoming IMPACT-CABG II trial will evaluate higher cell doses and pharmacologic enhancement to determine whether these cells improve perfusion and myocardial function.

Nephro-Urology Monthly

Effects of human Umbilical Cord Stem Cells and Granulocyte Colony- Stimulating Factor (G-CSF) on Carbon Tetrachloride-Induced Nephrotoxicity

Article

Author: Ayhan Dalkilic ; Nezaket Eren ; Abdulkadir Unsal ; Elbis Ahbap ; Yener Koc ; Mehmet Sokmen ; Tamer Sakaci ; Sebnem Cigerli ; Aysim Ozagari ; Taner Basturk

BACKGROUNDRecently, stem cells have been used to facilitate healing in animal models of renal failure induced by acute ischemic and nephrotoxic damage. Granulocyte colony-stimulating factor (G-CSF) has been reported to stimulate stem cell mobilization from bone marrow and these cells may contribute to renal repair.OBJECTIVESIn the present study, the effects of G-CSF and stem cell administration as monotherapy or in combination, and the relation of these effects with the duration of therapy, have been investigated in an experimental rat model of carbon tetrachloride (CCl4)-induced nephrotoxicity.MATERIALS AND METHODSThe fifty rats included in the study were distributed into 4 main groups, Group 1, 2, 3, and 4, and two subgroups for each group, except for Group 1. All rats received an intraperitoneal injection of CCl4. Then at 6 h, Groups 1, 2a, 3a, and 4a were administered saline, stem cells, G-CSF, and stem cell plus G-CSF, respectively. At 24 h, Groups 2b, 3b, and 4b were administered stem cells, G-CSF, and stem cell plus G-CSF, respectively. All animals were sacrificed 48 h after the CCl4 injections. Serum urea, creatinine, sodium, and potassium levels were measured from blood samples. Tissue α-glutathione S-transferase (GST) levels were also measured from renal tissues.RESULTSSerum urea was reduced in all groups when compared to Group 1, but the decrease was statistically significant only in Group 3b (P = 0.04). Serum creatinine and sodium levels were similar in all groups (P > 0.05). Tissue GST levels were lower in all groups, but the reduction was significant only in Group 4a, which was administered stem cells + G-CSF at 6 h (P = 0.01). Tubular degeneration and/or tubular dilatation were the most common pathologic changes, and their incidence was similar in all groups (P > 0.05).CONCLUSIONSAlthough both stem cell and G-CSF monotherapy led to damage reduction, the effect was not significant. However, the reduced damage by the combined use of stem cells and G-CSF, particularly during the early period, was statistically significant.

100 Deals associated with Stem cells(Honya Medical)

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