Cell therapy clinical trials – 2013 Report

by Alexey Bersenev on February 1, 2014 · 14 comments

in annual reports

This is 2013 report of registered clinical trials in cell therapy. Every year I overview some tracked data from international clinical trials databases. You can see previous annual reports here.

Definitions and criteria
I tracked clinical trials which fall in definition of cell therapy: administration of living cells in human with therapeutic purpose. Besides “traditional cellular products”, I also included tissue engineered constructs with cells, cellular gene therapy and use of cells as a vehicles for therapeutic agent delivery. I tracked all clinical trials which were registered from Jan.1, 2013 to Dec. 31, 2013 in international databases.

The following categories were excluded from analysis:
1. Cells for homologous use:

  • hematopoietic cells for recovery of blood formation in hematological malignancies;
  • gene-modified hematopoietic cells for correction of metabolism errors and inherited immune disiseases (example: SCID);
  • ex vivo expanded hematopoietic cells for enhancement of engraftment in hematological malignancies;

2. Platelet rich plasma trials
3. Extracorporeal devices with cells

Data mining strategy
“Hand coding” included:

  • using multiple key words and phrases
  • exclusion of overlaps between search results
  • exclusion of duplications between databases
  • reading trial description and “coding” the following categories: trial ID, country, phase, status, indication, cell type, donor type, type of sponsorship, name of company-sponsor, study acronym, number of patients in enrollment.

Key words:

  • “cell therapy”
  • “stem cell”
  • “cord blood”
  • “umbilical cord”
  • “bone marrow”
  • “cancer vaccine”
  • “tissue engineering”
  • “cellular”

Total number of trials tracked: 323
Number of duplications between databases: 7

Databases
The following databases were scanned:
US NCT (NIH-FDA)
European EUCTR (EudraCT)
Japanese UMIN, JMA CCT, Japic
Indian CTRI
Chinese ChiTCR
Iranian IRCT
Australian/NZ ANZCTR
UK ISRCTN
Dutch NTR
South Korean CRIS

All international databases, except NCT, were scanned via WHO Search Portal (ICTRP). Each database was checked separately to capture everything, missed by ICTRP.

Databases representation:

databases13

Demographics:

countries13

regions13

Sponsorship
All trials were divided on 2 categories – “academic” and “industry”. The term “academic” combined any monetary support (governments, funds…) other than “company-sponsored” (“industry”). Term “industry” also included companies – collaborators, when sponsorship is not clear from trial description and when company manufactured/ provided cellular material.

sponsor13

Cell types
More than 30 different cell types were assessed in clinical trials in 2013. Some trials included more than one cell type (in different groups or mixed).

majorcelltypes13

MSC13

immunecells13

othercelltypes13

donortype13

Abbreviations: MSC – 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, SVF – stromal vascular fraction; MB – mobilized blood; T-regs – regulatory T-cells; iPS – induced pluripotent stem cells; MAPC – multipotent adult progenitor cells.

Indications:

indications13

Special considerations:

  1. This is a snapshot of some data, which I’ve been collecting during the year. If you would like to collaborate on data mining, please contact me.
  2. These data were not validated by independent expert.
  3. How to cite: Bersenev Alexey. Cell therapy clinical trials – 2013 report. CellTrials blog. February 1, 2014. Available: http://celltrials.info/2014/02/01/2013-report/
  4. You’re free to share these data with appropriate credit under CC BY-ND 3.0 license.

You can follow real time updates via @CellTrials

{ 14 comments… read them below or add one }

Cornel M February 1, 2014 at 1:36 pm

Alexey,

This is great info. Thanks for your hard work and informative tweets.

Reply

Alan Lewis February 2, 2014 at 11:56 am

Appreciate your review. Thank you, Alexey!

Reply

Erik Woods February 3, 2014 at 10:07 am

Very nice break down and presentation method. Thank you for the hard work!

Reply

Falk Heinrichsohn February 3, 2014 at 5:56 pm

Excellent overview, Thank you

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Kathy Loper February 10, 2014 at 11:07 am

Thank you for assembling this information. Nice presentation!

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Jessie H.-T. Ni February 10, 2014 at 11:23 am

Thank you for the excellent review and the data stat., as always.

Reply

Valerie Kellogg February 17, 2014 at 2:06 pm

Excellent review of clinical trial data. Thank you for all of your hard work in pulling this together.

Reply

Keshav Ramu February 26, 2014 at 2:48 am

Thank you very much for your valuable information…..
Regards
keshav

Reply

Matti Korhonen, MD March 3, 2014 at 3:51 am

Thanks for your hard work. This is really helpful for getting a wider picture of what is going on.

Reply

Dr M.Chandrashekhar June 7, 2014 at 11:45 pm

Excellent compilation of data, Alexey—- year after year. Though I saw this Report late, nevertheless, it was a lovely scientific treat.

Reply

Nedunchezhian June 8, 2014 at 12:45 am

Thanks for the excellent work done.

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Tony Simula June 11, 2014 at 3:09 am

Great overview Alexey. Thanks for making my job a little easier.

Reply

Vasanthi August 11, 2014 at 12:40 am

Excellent overview Alexy!. Thanks so much for your hard work and excellent compilation.

Reply

Irfan December 1, 2014 at 7:01 pm

Very well written and comprehensive report about the clinical uses of stem cells. It is surprising to know that no study is available about ESCs. I appreciate your efforts for stem cells community.

Reply

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