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.
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.
- “cell therapy”
- “stem cell”
- “cord blood”
- “umbilical cord”
- “bone marrow”
- “cancer vaccine”
- “tissue engineering”
by name of company
Total number of trials tracked: 372
Number of duplications between databases: 8
The following databases were scanned:
US NCT (NIH-FDA)
European EUCTR (EudraCT)
Japanese UMIN, JMA CCT
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.
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.
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.
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.