BioInformant

Your Global Leader in Stem Cell Market Research

MENUMENU
  • Blog
    • Interviews
  • News
  • Stem Cells
    • iPS Cells
    • MSCs
    • HSCs
    • Adipose SCs
    • Neural Stem Cells
  • Exosomes
  • CAR-T
  • Cord Blood
  • Shop
    • Products
    • Submit PR
    • Advertise
  • About
    • Testimonials
    • Story
    • Guarantee
    • Contact
  • Home
  • Blog
    • Stem Cells
      • HSCs
      • iPS Cells
      • MSCs
      • Neural Stem Cells
      • Adipose SCs
    • Exosomes
    • Cell Therapy
      • CAR-T
    • Cord Blood
    • Stem Cell News
    • Interviews
  • COVID-19
  • Shop
  • Submit PR
  • Company
    • Advertise
    • Testimonials
    • Story
    • Job Posts
    • Guarantee
    • Privacy Policy
    • Contact
Home » World’s First Clinical Application of iPS Cells for Cardiac Disease

World’s First Clinical Application of iPS Cells for Cardiac Disease

June 2, 2018 By Cade Hildreth (CEO) Leave a Comment

On 16 May, Nature News reported that “Japan’s health ministry gave doctors at Osaka University permission to take sheets of tissue derived from iPS cells and graft them onto diseased human hearts.” The team of Japanese doctors, led by cardiac surgeon Yoshiki Sawa at Osaka University, will use iPS cells to “create a sheet of 100 million heart-muscle cells.”

Discover class-defining bioproduction tools.

From preclinical studies in pigs, the team determined that thin sheets of cell grafts can improve heart function, likely through paracrine signalling. Paracrine signalling is a type of cell-to-cell communication through which cells “talk” to one another, often regulating inflammation, fibrosis (scarring), and and cellular recovery.

While the treatment will only be tested in three patients, a follow-up trial could enroll ten or more patients. Under Japan’s accelerated regulatory pathway for regenerative medicines (cell, gene and tissue products), Dr. Sawa’s iPS cell therapy could be conditionally marketed to the public if a follow-up trial demonstrated safety and an initial proof of efficacy.

Launched in late 2014, Japan’s fast-track system allows for regenerative therapies to receive conditional marketing authorization for up to 7 years, following confirmation of safety and an initial proof of efficacy in Japan in diseases that are serious and have a high unmet need.

Rooster DevServices

This program is formally known as “Conditional Time-Limited Marketing Authorization” in Japan.

Clinical Application of iPS Cells

2013 was the first time in which clinical research involving transplant of iPSCs into humans was initiated, led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB) in Kobe, Japan. In this RIKEN study, Dr. Takahashi used iPSC-derived cell sheets in patients with wet-type age-related macular degeneration.

bitbio

Unfortunately, the RIKEN study was suspended in 2015 due to safety concerns. As the lab prepared to treat the second trial participant, Yamanaka’s team identified two small genetic changes in the patient’s iPSCs and the retinal pigment epithelium (RPE) cells derived from them.

However, in June 2016, RIKEN announced it would resume the clinical study, this time using allogeneic rather than autologous iPSC-derived cells to lower the time and cost burdens.

Pluristyx

Therefore, the new cardiac study at Osaka University will be the second clinical application of iPS cells in Japan and third worldwide, as Cynata Therapeutics also has a clinical trial underway with an allogeneic iPS cell-derived therapeutic (CYP-001).

In September 2016, Cynata Therapeutics received approval to initiate a clinical trial using an allogeneic iPS cell-derived cell product, which it calls “CYP-001.” The study involves centers in  the UK and Australia.

iPSC-derived cardiomyocte therapy

In this trial, Cynata is testing an iPS cell-derived mesenchymal stem cell therapeutic product for the treatment of Graft-vs-Host-Disease (GvHD).

The trial is named “A Study of CYP-001 for the Treatment of Steroid-Resistant Acute Graft Versus Host Disease” and can be viewed here.

To learn more, view the “Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report.“

What do you think of Japan’s authorization of this clinical research? Are the safety risks worth the benefits? Leave your comments below.
5/5 - (6 votes)

Filed Under: iPS Cells, Stem Cell News Tagged With: cardiac, iPS cells, Japan

Related

About Cade Hildreth (CEO)

Cade Hildreth is the Founder of BioInformant.com, the world's largest publisher of stem cell industry news. Cade is a media expert on stem cells, recently interviewed by the Wall Street Journal, Los Angeles Business Journal, Xconomy, and Vogue Magazine. 

Tell Us What You Think! Cancel reply

Nanocellect

Marathon Products

Kimera Society

Let’s Get Social

  • Facebook
  • Twitter
  • LinkedIn
  • Pinterest
  • Instagram

Cart

Featured Posts

clean meat market

Clean Meat Market: Stem Cell Derived “Clean Meat” Attracts Billionaires

what are exosomes | definition

What are Exosomes, Exactly?

Who discovered stem cells?

Who Discovered Stem Cells? The Answers Revealed

My Tweets

BioInformant's World-Class Clients

  • Submit Press Release
  • Advertise
  • Privacy and Terms

Copyright © 2022 · BIOINFORMANT, Your Global Leader in Stem Cell Market Research

| Email: [email protected] | Phone: 703-859-7617 |

800 Corporate Drive, Suite 301, Stafford, VA 22554, United States

Disclaimer: All statements made on this website are NOT expressed as medical claims or advice. They are not intended to diagnose, treat, cure or prevent any disease or condition. If you have a health condition or concern, consult your physician or health care provider.