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FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36

September 24, 2019 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Peter-Marks-Regenerative-Medicine-Advanced-Therapy-Designation-RMAT-

This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm […]

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Updated FDA granted RMAT List (85)

January 10, 2018 / Professor Paul Knoepfler, Ph.D.

Today’s post includes a list of firms/products that have self-reported that they have received FDA regenerative medicine advanced therapy designation or RMAT. Sometimes people call these “r mat” with a space. As of December 12, 2023 there are 85 RMATs in the public domain. I also include FDA data on RMAT submissions via an FDA RMAT resource

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Grading my twenty 2017 stem cell predictions

December 20, 2017 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Each year I make a list of predictions for the year to come for the stem cell and regenerative medicine field. Then about a year later I grade myself on how I did as that year winds down. Here’s how I did in 2016. For 2017, late in 2016 I made 20 stem cell predictions. Let’s

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2017 stem cell predictions: score card at 1/2-way point

June 18, 2017 / Professor Paul Knoepfler, Ph.D. / 1 Comment

In December of each year I make a list of stem cell predictions for the coming year, and I made 20 such predictions for 2017 so I’m wondering how I’m doing so far on these now that it’s June. Below is my work-in-progress scorecard for these so far. Positive news from Asterias on trial for stem cell-based

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Stem Cell Predictions for 2017

December 29, 2016 / Professor Paul Knoepfler, Ph.D. / 7 Comments

Each year I make a list of predictions for the stem cell and regenerative medicine field for the coming new year. Later in this post I list my top 20 stem cell predictions for 2017. In looking at my past predictions I realized this will now be my 7th year doing stem cell/regenerative medicine yearly predictions.

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Cynata approval for 1st ever allo trial of IPSC-derived MSCs for GVHD

September 22, 2016 / Professor Paul Knoepfler, Ph.D. / 6 Comments

Cynata Therapeutics Limited has received approval from UK regulators to start a first-of-its-kind allogeneic IPSC-based trial of MSCs for graft versus host disease (GVHD). Cynata also had some big news a couple weeks back with a deal with Fujifilm. The company is aiming to recruit 16 patients to test whether the MSCs (a type of adult

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First impressions of the US stem cell environment from an Aussie

January 21, 2016 / Professor Paul Knoepfler, Ph.D. / 7 Comments

Editor’s note: this is a guest post on the US stem cell environment. By Heather Main I moved to the San Diego from Australia in August 2015, and Paul asked me if I could write something on my first impressions of doing science in the US, as opposed to other countries I have worked/studied in

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Stem cell treatment cost 2.0: legit therapy

October 8, 2015 / Professor Paul Knoepfler, Ph.D. / 4 Comments

We hear so much about exciting potential stem cell therapies, but what about stem cell treatment cost? Some of these “therapies” are rigorously evaluated ones in the FDA clinical trial pipeline and others are available right now mainly through predatory stem cell clinics. Earlier this year I posted about the cost of the offerings of

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Great News: FDA Nod For ViaCyte IND of Diabetes Stem Cell-Based Product

August 20, 2014 / Professor Paul Knoepfler, Ph.D. / 8 Comments

Type 1 Diabetes is a huge global problem. Where are the solutions that would compliment or replace insulin therapy for diabetics? There haven’t been too many that have gotten very far, which makes the news of a potential stem cell-based therapy moving along in the pipeline all the more exciting. ViaCyte (see more posts here,

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Book Excerpt: Stem Cell For-Profit Good Citizen Biotechs

January 17, 2014 / Professor Paul Knoepfler, Ph.D. / 2 Comments

The below is an excerpt from my book, Stem Cells: An Insider’s Guide. I hope you enjoy this excerpt and the book, which I think is a really good deal at under $27 paperback or under $17 for E-book version. Having our innovation and ethics too In the stem cell field you can have it

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