Cell therapy clinical trials in 2011

by Alexey Bersenev on January 4, 2012 · 21 comments

in clinical trials and cases

Post to Twitter

In April 2011 I’ve started a new project – Cell Therapy Trials. This is a prototype for tracking of clinical trials and cases in cell therapy field with publicizing it via Twitter. The big part of the project is collection of clinical data via tracking of published literature, conference reports and business press-releases. Today I’d like to share with you some results of this project – tracking of registered clinical trials in 2011.

Data collection criteria
I tracked clinical trials which fall in definition of cell therapy: administration living cells in human with therapeutic purpose. I included tissue engineering and excluded devices for cell processing. I tracked all clinical trials which were registered in 2011 in international databases.

“Registered” doesn’t necessarily mean “new”. Some trials were registered in late phases (2/3 or 3) or listed as completed. Because trials, registered in late stages consist only ~ 3.7%, I include all of them in the analysis. The vast majority of trials (>95%), registered in 2011, were in early stages (1-1/2-2). I called these trials “new”. The status of the most “new” trials was “recruiting” or “not open yet” (just launched). I think, it reflects real situation in cell therapy activity around the world.

I collected data about all cell therapy trials, excluding hematopoietic stem/ progenitor cells for homologous use (hematology – oncology). This approach allows to get a sense about activity in cellular immunotherapy and regenerative medicine.

Data access
I input raw data in spreadsheet. The data include: trial id, hyperlink to trial, country, phase, status, condition, cell type, allogeneic/ autologous, academic/ industry-sponsored. This document is publicly available. Everyone can use and play with these data!

Number of trials: I was able to track 151 trials.

Databases scanned:
US NCT (NIH-FDA)
German DRKS
Japanese JPRN
Indian CTRI
Chinese ChiTCR
Australian/NZ ANZCTR
ISRCTN
Dutch NTR
South Korean CRIS

Worldwide activity:

Monetary support:
I roughly divide all trials on 2 categories – “academic” and “industry”. The term “academic” combined any monetary support (governments, funds…) other than “company-sponsored” (“industry”).

Cell types:
I was able to identify roughly 25 different cell types used in clinical trials. I roughly divide them on “stem” and “non-stem”. “Stem” cell types included: embryonic stem cells, multipotent mesenchymal stromal cells, hematopoietic stem/ progenitor cells, cardiac stem/ progenitor cells, neural stem cells, CD133+ cells.


Abbreviations: ESC – embryonic stem cells, MSC – multipotent mesenchymal stromal cells, HSPC – hematopoietic stem/ progenitor cells, TIL – tumor-infiltrating lymphocytes, DC – dendritic cells, BM – bone marrow, MNC – mononuclear cells, NK – natural killer cells, CIK – cytokine-induced killers, SC – stem cells.

Indications:

Future development:

  • trends identification
  • analysis of trials outcome via published results
  • collaboration and data representation

Source: @CellTrials

How to cite: Bersenev Alexey. Cell therapy clinical trials in 2011. Hematopoiesis blog. January 3, 2011. Available: http://hematopoiesis.info/2012/01/04/cell-therapy-trials-2011

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  3. Cell therapy clinical trials 2009 – part IV
  4. Cell therapy clinical trials 2009 – part II
  5. Cell therapy clinical trials 2009 – part I