Active phase III or II/III cell therapy trials

By Dr. Matthew Watson

I know that the moment I publish anything that purports to be comprehensive there will be errors and omissions. At the very least it will almost imminently be out-of-date in a fast-moving sector like cell therapy.

Nonetheless, because there is no other reliable repository of this information, I am daring to put this out there and hope you will feel obligated to assist me in ensuring its accuracy rather than critical of the effort.

What follows is what I currently believe to an current and relatively comprehensive list of phase III or II/III cell therapy trials around the world. I am more confident of the industry list than the academic one. More confident of its completeness and accuracy for North American and Europe than of Asia (particularly China).

There is a spreadsheet behind this that includes more data fields like therapeutic category, cell/tissue source, cell type, expansion, indication, expected completion date, clinical trial site locations, etc. If you want a copy of it, just email me (I'm not hard to find) or comment below.

INDUSTRY PHASE III or II/III (active or expected to be active in 1H 2012)

Aastrom Ixmyelocel-T

Baxter ACT34-CMI

Bioheart Myocell

Cardio3 Biosciences C-CURE

Cell Medica adoptive cellular therapy

Cook Myosite AMDC

Cytori ADRCs

GamidaCell - Teva StemEx

Genzyme MACI

Harvest Technologies SmartPReP 2 BMAC

Innovaell IES13 (Urocell?)

Kiaidis Pharma ATIR

Miltenyi CliniMACS CD34 Selection System

Medipost Cartistem

MolMed TK

Newlink Genetics HyperAcute Pancreas

NovaRx Lucanix

Osiris Prochymal

Pervasis Vasugel

The 21 active or imminently active cell therapy industry-sponsored trials listed above break down as follows:

52% (12) are autologous
33% (7) are allogeneic
Two are gene-modified allogeneic
One involves autologous and allogeneic cells

24% (5) are for cardiac-related indications
33% (7) are for oncology or related indications
Two are for cartilage repair

* ACADEMIC PHASE III or II/III

Assistance Publique - Hôpitaux de Paris (France)
Association of Dutch Burn Centres (Netherlands)
Barts and The London NHS Trust (UK)
Erasmus Medical Center (Netherlands)
European Group for Blood and Marrow Transplantation (Europe)
Leiden University Medical Center (Netherlands)
Meshalkin Research Institute of Pathology of Circulation (Russia)
Meshalkin Research Institute of Pathology of Circulation (Russia)
Ministry of Health (Malaysia)
Royan Institute (Iran)
Rush University Medical Center, University of Sao Paulo, Uppsala University (US, Brazil, Sweden)
Third Military Medical University (Chia)
University of Minnesota, Masonic Cancer Center (US)
University of Minnesota, Masonic Cancer Center (US)
University Hospital of North Norway (Norway)
University of Utah (US)

* Active trials only - excludes trials which appear inactive, abandoned, and/or are stem cell transplant in oncology. Primary source is CinicalTrials.gov.

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I will try to keep this list updated at least once-per-quarter and indicate the date of the last update at the top of the post.

I eagerly encourage all readers to comment below or email direct with any errors and/or omissions.

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