Cell therapy clinical trials – 2013 Report

by Alexey Bersenev on February 1, 2014 · 13 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.

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