AmStem begins consumer study of human stem cell cosmeceutical

Published: 25-Jun-2010
Regulatory Skin Care

Korean stem cell research specialist studies SteMixx as prelude to US IRB trial


Korean stem cell research company AmStem Corporation is to launch a consumer trial for its flagship cosmeceutical product SteMixx as a prelude to its first Institutional Review Board approved clinical trial in the US next month.

Participants in the study will use SteMixx – derived from human stem cells collected from the umbilical cord immediately after birth – for a month providing data of efficacy, product characteristics and satisfaction. This will be used to support SteMixx’s full launch in high-end retail and wholesale next quarter.

“AmStem is committed to the highest ethical and professional standards in the field,” comments the company’s president, David Stark. “In fact the protocol we are employing is much more rigorous than most consumer-based cosmetic studies. It involves strict inclusion and exclusion criteria. Participants must refrain from using other facial cosmetics for one month.”

According to AmStem, SteMixx has already gained Korean FDA approval as a ‘functional cream’ for treating age-related skin issues.
  • Companies:
  • AmStem Corporation
See more

You may also like

Regulatory

Accelerating and enhancing toxicology assessments

Read more
Infographic guides users through ToxHQ’s speedy assessment features

Trending Articles

  1. Accelerating and enhancing toxicology assessments Infographic guides users through ToxHQ’s speedy assessment features
  2. You need to be a subscriber to read this article.
    Click here to find out more.
    Merck jumps on the GLP-1 therapeutic bandwagon by licensing Hansoh Pharma's HS-10535 Merck will be responsible for the development, manufacture and commercialisation of the investigational preclinical oral GLP-1 receptor agonist
  3. Bayer's acoramidis recommended for approval by the EMA's CHMP for cardiomyopathy The orally administered transthyretin (TTR) stabiliser is suitable for patients with transthyretin amyloid cardiomyopathy, demonstrating at least a 90% TTR stabilisation capacity and a reduction in cardiovascular-related hospitalisations
  4. You need to be a subscriber to read this article.
    Click here to find out more.
    Why quality control should be intimately combined with sterile product development, manufacturing and the overall product supply chain With sponsor companies increasingly needing to create and launch differentiated, stable, usable and safe injectable treatments for patients, experts at ten23 health are keen to promote the importance of integrating development and/or manufacturing with quality control services
  5. The right validation model: practical considerations and applications It is widely accepted that validation in the life sciences industry follows a lifecycle model (1,2). What is not always clear is the specific model — or models — to follow and how to navigate through them in the real world. Hurdles to overcome include the specific deliverables that make up that model and how they change during the various interactions along the validation journey

Upcoming event

EMPQ Essentials and Real-World Strategies for Successful Cleanroom Qualifications

16 January 2025 | Virtual See all

You may also like

Regulatory

Accelerating and enhancing toxicology assessments

Infographic guides users through ToxHQ’s speedy assessment features
You need to be a subscriber to read this article.
Click here to find out more.
Regulatory

Merck jumps on the GLP-1 therapeutic bandwagon by licensing Hansoh Pharma's HS-10535

Merck will be responsible for the development, manufacture and commercialisation of the investigational preclinical oral GLP-1 receptor agonist
Regulatory

Bayer's acoramidis recommended for approval by the EMA's CHMP for cardiomyopathy

The orally administered transthyretin (TTR) stabiliser is suitable for patients with transthyretin amyloid cardiomyopathy, demonstrating at least a 90% TTR stabilisation capacity and a reduction in cardiovascular-related hospitalisations
You need to be a subscriber to read this article.
Click here to find out more.
Manufacturing

Why quality control should be intimately combined with sterile product development, manufacturing and the overall product supply chain

With sponsor companies increasingly needing to create and launch differentiated, stable, usable and safe injectable treatments for patients, experts at ten23 health are keen to promote the importance of integrating development and/or manufacturing with quality control services
Regulatory

Asahi Kasei Pharma grows its global portfolio with anti-CX3CR1 license

The licensing deal with Chiome enhances its open innovation platform
Manufacturing

Solvent recycler SPR-200 boosts sustainability in pharma labs

Recycling up to 90% of solvent in isocratic HPLC improves lab efficiency and sustainability
Regulatory

Accumulus Synergy teams up with CEPI to expedite the vaccine regulatory approval process

Through Accumulus' cloud-based technology, the two organisations aim to accelerate the accessibility of data for the regulatory approval process of vaccines globally, enhancing the world's pandemic 'preparedness'
Subscribe now