Cell therapy clinical trials – 2014 Report

by Alexey Bersenev on January 22, 2015 · 6 comments

in annual reports

This is 2014 report of registered cell therapy clinical trials. Every year I give a snapshot of some tracked data, captured from international clinical trials databases. You can see previous annual reports here.

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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, 2014 to Dec. 31, 2014 in international registries.

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

  • hematopoietic cells for recovery of blood formation in hematological malignancies or for recovery of hematopoiesis after chemotherapy for treatment of solid tumors;
  • gene-modified hematopoietic cells for correction of metabolism errors and inherited immune diseases (example: SCID);
  • ex vivo expanded hematopoietic cells for enhancement of engraftment in hematological malignancies;

2. Platelet rich plasma trials
3. Extracorporeal devices with cells (no administration of cell inside of body).

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”
    • “mesenchymal”
    • “adipose”

by name of company

Total number of trials tracked: 372
Number of duplications between databases: 8

Databases
The following databases were scanned:
US NCT (NIH-FDA)
European EUCTR (EudraCT)
Japanese UMIN, JMA CCT
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:

databases14

Demographics:

countries14

regions14

Sponsorship
All trials were divided on 2 categories – “academic” or “industry”. The term “academic” combined any monetary support (governments, funds, charities…) other than company-sponsored. Term “industry” also includes (1) companies – collaborators, when sponsorship is not clear from trial description and when company manufactured/ provided cellular material, (2) commercial for-profit clinics with unclear regulatory authorization.

sponsorship14

Cell types

donortype14

majorcelltypes14

MSC14

immunecells14

othercells14

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; ESC – embryonic stem cells; CAR – chimeric antigen receptor; CB – cord blood; DLI – donor lymphocyte infusion.

Indications:

indications14

This is a first snapshot from 2014 report. I’m planning to post trends analysis, trials results analysis and some other data. Stay tuned!

How to cite:
Bersenev Alexey. Cell therapy clinical trials – 2014 report. CellTrials blog. January 22, 2015. Available: http://celltrials.info/2015/01/22/2014-report/

You’re free to share these data with appropriate credit under CC BY-ND 3.0 license.

{ 6 comments… read them below or add one }

Jim Hardy January 26, 2015 at 12:34 am

Great work Alexy. Thank you for sharing.

Reply

Tim Oldham January 30, 2015 at 4:48 pm

Alexey,
Wonderful analysis. Do the numbers change materially if you run them just on the industry sponsored 30% of trials?
Tim

Reply

Tony Simula February 11, 2015 at 6:28 pm

Hi Alexey,
Great effort! Really enjoy your website. Looking forward to your follow up trend analyses.
Tony

Reply

John R. Jaskowiak February 16, 2015 at 3:58 pm

Nice work. What was the rationale for excluding cells for homologous use from the data collection?

Reply

Rob July 22, 2015 at 9:10 am

Good work! Now this is really big collection of analyses and informations. Keep it up, as it was interesting.

Reply

amir October 1, 2015 at 8:46 am

very nice analysis report Alexey
Looking forward to your follow up trend analyses.

regard
amir

Reply

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