Cell therapy clinical trials – 2012 report

by Alexey Bersenev on January 8, 2013 · 11 comments

in annual reports

This is an annual report of registered clinical trials in cell therapy. Every year I overview some tracked data from international clinical trials databases. You can see 2011 report here.

Definitions
I tracked clinical trials which fall in definition of cell therapy: administration of living cells in human with therapeutic purpose. I included tissue engineering, cellular gene therapy and devices for cell processing. I tracked all clinical trials which were registered from Jan.1, 2012 to Dec. 31, 2012 in international databases.

Exclusion criteria:
Trials, assessing cell therapy for homologous use were excluded from analysis. Examples: (1) hematopoietic cells for recovery of blood formation (in hematological malignancies) or (2) ex vivo expansion of hematopoietic cells for enhancement of engraftment in hematological malignancies.

Hand coding and data collection
“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.

Search key words:
“cell therapy”
“stem cell”
“cord blood”
“umbilical cord”
“bone marrow”
“cancer vaccine”
“tissue engineering”

Total number of trials tracked: 226
Number of duplications between databases: 6

Databases
The following databases were scanned:
US NCT (NIH-FDA)
European EUCTR
Japanese JPRN
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.
Databases representation:

dbs

Demographics:

regions

countries

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.

sponsor

Cell types
I was able to identify 36 different cell types used in clinical trials. All cell types were roughly divided on “stem” and “non-stem”. “Stem” cell types included: embryonic stem cells, mesenchymal stromal cells, hematopoietic stem/ progenitor cells, cardiac stem/ progenitor cells, fetal neural stem cells, CD133+ cells, limbal stem cells, dental pulp stem cells, adipose stromal vascular fraction.

svns

stem

non-stem

I was able to identify 7 different types of MSC, based on source:

msc

Abbreviations: SC – stem cells; ESC – embryonic stem cells, 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; EPC – endothelial proogenitor cells; MPB – mobilized peripheral blood.

Cell donor type:

donor

Indications:

indications

This was a snapshot of data, which I’ve been collecting during the year. More analysis and trends are coming.
You can follow real time updates via @CellTrials

How to cite:
Bersenev Alexey. Cell therapy clinical trials – 2012 report. CellTrials blog. January 8, 2013. Available: http://celltrials.info/2013/01/08/2012-report/

{ 11 comments… read them below or add one }

gary peltz January 10, 2013 at 2:00 pm

your clinical trials blog was a great help. can u tell me the identity of the 10 clinical trials for liver disease indicated on the jan 8, 2013 posting?

thank you

gary peltz

Reply

Alexey Bersenev January 11, 2013 at 6:26 pm
ARGENTIN DIDIER January 15, 2013 at 7:35 am

Great job Alexey,
Do you have any explanation for the sharp increase vs 2011 (151 trials registrated vs 226 in 2012) ?
Is this due to the fact that you only began in April 2011 and added 2 DB in 2012 or does it really reflect a marked increase in the number of cell therapy trials ?
Best regards,
Didier Argentin

Reply

Alexey Bersenev January 16, 2013 at 12:15 am

Yes, I think it reflects real marked increase. The potential explanation I gave in today’s post:
1. Increased interest to the field, so yes it is very real increase in number of trials.
2. Trialists were more encouraged to register trials to make world know about it. It is kind of “promotion”, why not submit in database?
3. Some countries mandate to submit trials in databases (it possibly was implemented more in 2012 than in 2011).
4. I used more key words in 2012 than in 2011, so I may capture more trials.

Reply

Sarah ho June 27, 2013 at 9:34 pm

Hi Alexey,

thank you so much for the update. I learn a lot about the field from your posts. There is an increase from 2011 to 2012 in term of clinical trials. May I ask how does the trend like in the previous years?

Reply

Helena January 21, 2013 at 7:03 pm

Hello,
I’ve started reading your post’s not long ago, and I’m finding it very educational.
Since I’m still new at this I have some basic questions… perhaps you could help me.
So, I found this report you made very interesting, nevertheless I’m used to hearing that are thousands of clinical trials with stem cells and You only report 123 starting 2012. what do you think of this?
Can you point me which clinical trials is using dental pulp stem cells?
I also couldn’t figure what MPB stands for, can you help me?
Thanks
Helena

Reply

Alexey Bersenev January 24, 2013 at 11:14 pm

Helena,
If you type search query “stem cell” in clinicaltrials.gov database you will get >4000 results. It doesn’t mean that all of these trials assess administration of cells as therapeutic modality. Most of them are assessing drugs as part of therapy in bone marrow transplantation (hematology-oncology) clinic. If you sort it out, you still will get a big number, but as I said, in my analysis I didn’t include the use of hematopoietic cells for homologous use (means for rescuing of blood formation). If you narrow down your search to 2012 and use a “hand coding” to sort out real things, you will get a number close to 123.

MPB stands for “Mobilized Peripheral Blood”.

Dental pulp trial:
http://apps.who.int/trialsearch/Trial.aspx?TrialID=JPRN-UMIN000009441

Reply

Dominic May 1, 2013 at 11:47 am

Hi Alexey,
Very good info – thank you for putting this together. Do you happen to have a breakdown of the trials into clinical phases? That would be very helpful especially if we can also compare to 2011. It would help to see percentage of trials in the various clinical phases and the potential shift from 2011 through 2012. Thanks in advance!

Dominic

Reply

Alp Can January 10, 2015 at 6:54 am

Dear Alexey;

You put together a very good documentation. Would you think to repeat the same search protocol for the beginning of 2015.
Many thanks in advance.

Prof. Alp Can
Stem Cell Clinical Trial PI

Reply

Alexey Bersenev January 11, 2015 at 10:56 am

Hi Alp Can,
Yes, I’m planning to post 2014 report some time before Feb. this year.

Reply

Matt MIller May 20, 2015 at 6:54 pm

This is valuable information. I am interested to see what sorts of trials took place during the 2014 calendar year. What I have found is that trends in trials will lead CROs to strive to become more specialized and have a broader range of therapeutic expertise. Recently, I have seen a huge surge in orphan drug/rare disease research; research companies are sure to follow suite of the pharmaceutical industry. Essentially, if the pharma/biotech industry establishes a demand for it, then the CRO sub-industry will respond in kind trying to meet that demand.

Reply

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