Pioneering treatments: planning first-in-human stem cell clinical trials

Sometimes the reason for the most complex of projects can be boiled down to the most simple of phrases.

Dr. John Adams, Dr. Catriona Jamieson & Dr. John Zaia at the Alpha Stem Cell Clinic network meeting

(left to right) Dr. John Adams, Dr. Catriona Jamieson & Dr. John Zaia at the Alpha Stem Cell Clinic network meeting

At a meeting last week to help plan for our Alpha Stem Cell Clinic network there were lots of great presentations and discussions about the role of the network, how to structure it, what its goals would be. But in the end it was all beautifully, and succinctly, summed up by Dr. Catriona Jamieson who said: “This is great for humanity and this is why we have to do it.”

Dr. Jamieson is heading the University of California, San Diego (UCSD) part of the network. Other partners in this program are City of Hope, UC Los Angeles (UCLA) and UC Irvine (UCI). The goal is to create a network of stem cell-focused clinics that will attract and conduct high quality clinical trials. The stem cell agency is investing $24 million to help create that network.

Why do we need this? Well, stem cells are a whole new way of treating disease, one that requires new skills and expertise, and a new way of working with patients so they understand exactly what is happening.

Many of these clinical trials will be the first time these therapies have been tested in people so Shirley Johnson, RN, the Chief Nursing Officer overseeing the City of Hope program, says you need to have specially trained staff involved.

“We really look to our research patients as being our heroes and particularly our patients that are participating in those first-in-human studies. So having nurses who understand the study protocols, who understand the potential side effects that might be occurring, the symptoms that might be manifested are critical points as we think about first-in-human studies and those things that might occur, and then how best to respond to them.”

One of the reasons we are creating the Alpha Stem Cell Clinic network is because it fits in perfectly with our mission of accelerating the development of stem cell therapies to help patients with unmet medical needs. The network will not just focus on planning and carrying out clinical trials, but will also focus on how those treatments will be paid for, so that life-changing therapies won’t cost patients an arm and a leg.

Dr. John Adams, who heads the UCLA-UCI program, says there will be many obstacles to overcome, but that this is an exciting time:

“The idea behind the Alpha Clinics is to provide an infrastructure to accelerate and make it dead easy for the researchers doing this work to get their work done efficiently, effectively and faster, so that it’s more beneficial for the patients who are undergoing the treatment. And certainly it will allow us to collect more data, and better data, during the course of these clinical trials.”

The data gathered in these trials, and the lessons learned in doing them, will then be shared with others in the network to help create a system of best practices, to make it easier to carry out future clinical trials.

As Dr. John Zaia, who heads the program at City of Hope says: “This is really the beginning of a new era, the era of regenerative medicine.”

You can read more about our Alpha Stem Cell Clinic network, and find links to the individual programs here.

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3 thoughts on “Pioneering treatments: planning first-in-human stem cell clinical trials

  1. The Alpha clinics may turn out to be of enormous significance for the entire field, by establishing standards and setting up a smooth and easy place to perform the tests that can take soooooooo much time…..

  2. As Director and coordinator, I am representing an ongoing Parkinson’s educational and support group that is associated with The NeuroCommunity Foundation in Westlake Village, CA.
    We would be most interested to have a medical researcher who is involved in “Pioneering Treatments – First In-Human Stem Cell Clinical Trials” as a presenter at one of our monthly meetings in Westlake Vilage (possibly Friday, May 6, 2016 from 10:00 to about 11:00 a.m.). There unfortunately have been Stem Cell Therapy treatment presentations that provided questionable research by medical doctors who were looking for customers and our members with PD and their caregivers would be greatly assisted by a truly research based presentation that reflects the scientific state of the stem cell research with humans and, at the same time, perhaps engender hope.
    Please advise and thank you in advance for your kind consideration in this regard.

    Sincerly yours,

    David J. Clark, Ph.D.
    (805) 852-2431
    Director, Parkinson’s Support Group, Westlake Village
    Cc: Viviane Tondeur, MBA, Gerentologist, Educational Director
    The NeuroCommunity Foundation
    (818) 885-8623

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