Cell therapy clinical trials in 2011

by Alexey Bersenev on January 4, 2012 · 20 comments

in clinical trials and cases

Post to Twitter

In April 2011 I’ve started a new project – Cell Therapy Trials. This is a prototype for tracking of clinical trials and cases in cell therapy field with publicizing it via Twitter. The big part of the project is collection of clinical data via tracking of published literature, conference reports and business press-releases. Today I’d like to share with you some results of this project – tracking of registered clinical trials in 2011.

Data collection criteria
I tracked clinical trials which fall in definition of cell therapy: administration living cells in human with therapeutic purpose. I included tissue engineering and excluded devices for cell processing. I tracked all clinical trials which were registered in 2011 in international databases.

“Registered” doesn’t necessarily mean “new”. Some trials were registered in late phases (2/3 or 3) or listed as completed. Because trials, registered in late stages consist only ~ 3.7%, I include all of them in the analysis. The vast majority of trials (>95%), registered in 2011, were in early stages (1-1/2-2). I called these trials “new”. The status of the most “new” trials was “recruiting” or “not open yet” (just launched). I think, it reflects real situation in cell therapy activity around the world.

I collected data about all cell therapy trials, excluding hematopoietic stem/ progenitor cells for homologous use (hematology – oncology). This approach allows to get a sense about activity in cellular immunotherapy and regenerative medicine.

Data access
I input raw data in spreadsheet. The data include: trial id, hyperlink to trial, country, phase, status, condition, cell type, allogeneic/ autologous, academic/ industry-sponsored. This document is publicly available. Everyone can use and play with these data!

Number of trials: I was able to track 151 trials.

Databases scanned:
US NCT (NIH-FDA)
German DRKS
Japanese JPRN
Indian CTRI
Chinese ChiTCR
Australian/NZ ANZCTR
ISRCTN
Dutch NTR
South Korean CRIS

Worldwide activity:

Monetary support:
I roughly divide all trials on 2 categories – “academic” and “industry”. The term “academic” combined any monetary support (governments, funds…) other than “company-sponsored” (“industry”).

Cell types:
I was able to identify roughly 25 different cell types used in clinical trials. I roughly divide them on “stem” and “non-stem”. “Stem” cell types included: embryonic stem cells, multipotent mesenchymal stromal cells, hematopoietic stem/ progenitor cells, cardiac stem/ progenitor cells, neural stem cells, CD133+ cells.


Abbreviations: ESC – embryonic stem cells, MSC – multipotent 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, SC – stem cells.

Indications:

Future development:

  • trends identification
  • analysis of trials outcome via published results
  • collaboration and data representation

Source: @CellTrials

How to cite: Bersenev Alexey. Cell therapy clinical trials in 2011. Hematopoiesis blog. January 3, 2011. Available: http://hematopoiesis.info/2012/01/04/cell-therapy-trials-2011

Related posts:

  1. Tracking of clinical trials and cases in cell therapy and regenerative medicine
  2. Roadblocks for cell therapy clinical trials
  3. Cell therapy clinical trials 2009 – part IV
  4. Cell therapy clinical trials 2009 – part II
  5. Cell therapy clinical trials 2009 – part I

{ 20 comments… read them below or add one }

Jon Rowley January 5, 2012 at 1:04 am

Alexey

This is great. An extremely useful resource for the community. Keep up the great job supporting the Cell Therapy community!

Best from Maryland

Jon Rowley

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Sandy Kuligowski January 5, 2012 at 1:35 am

Alexey,
This information is very interesting and helpful in understanding current status and trends in the Cell Therapy field globally. I will continue to follow your updates.

Thanks for collating and sharing this information.

Best Regards,

Sandy Kuligowski

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Udaykumar January 7, 2012 at 4:32 pm

Excellent, very useful information. Thanks lot for collating and sharing the data.
Best
Uday

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scott broughton January 9, 2012 at 3:37 pm

Alexy; Agreed. Nice job, very informative and helpful in seeing trends for the future and advancement of cell therapy

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Mary McElroy January 19, 2012 at 3:52 pm

Alexy, many thanks for posting this research – very informative. Mary

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Cliff Carroll February 1, 2012 at 3:56 pm

Alexey, This is a fantastic collection of information. The visualizations are additionally extremely informative, but providing the spreadsheet was almost too kind. Thanks for all of your hard work.

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Marcos Levy February 3, 2012 at 12:09 pm

Alexey, great job, thanks for sharing
Regards

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Claudia Zylberberg February 3, 2012 at 12:44 pm

Great piece of information, very well put together

Claudia

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scott March 22, 2012 at 2:51 pm

Alexey. Great you are staying on top of this – really a full time job! No?
We are always trying to keep up with this and also in each trial, the number of patients. Some are small (10-20 safety), some are bigger (ongoing 50-100 patients) and larger commercial phase III (200 plus)… so we’ll share that with you at some point soon “as we see it”. Thanks… Scott

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Aline M. Betancourt, PhD April 5, 2012 at 6:59 pm

Alexey–great timing I will include some of your cool pics in a review chapter I am writing for Springer. I will send you the info. when it gets published. Thanks for ALL you do for cell-based therapies! Best wishes, ali

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Leeza Rodriguez May 30, 2012 at 6:34 pm

hi Alexey,

Thanks for all the work that went into this! I have been sifting thru the data and have a couple of questions. Please go easy–as you know I am not a phD, but rather an advocate who learned how to pivot on a G spreadsheet. :D

1) Could you please detail the indications that you consider ‘stem cell’ therapy. I read your May 9, 2011 post and this one, but I can not get my totals to match. I have been pivoting the G spreadsheet data in different ways .
From your column of tissue source category I am counting these exact descriptions as ‘stem cell’:

adipose SC
placental MSC
BM MSC
HSC mobilized
UC MSC
cord blood CD34+
adipose MSC
BM CD 133+
MSC
BM MNC
bone marrow HSC
cardiac progenitors
cord blood
cord blood MSC
adipose MSC
sclerocorneal progenitors -?
fetal neural SC
ESC
cardiac stem cells
HSC
mobilized CD34+ – ?
total BM concentrate

Can you please give me guidance for which of the above you do not consider to be stem cell therapy? Also are any missing from the above list? Once you advise, I will revisit. TIA-I really appreciate your time.

2) Trials using adipose stem cells
I am scratching my head over the low count recorded in your speadsheet for current trials with adipose stem cells. I have been combing thru a CT list from clinicaltrials.gov of all trials using adipose which are still recruiting. If I narrow the initial search results of 68 for ‘adipose’ AND ‘stem cells’ , I see more than 20 trials ‘recruiting’ for patients. Indeed some have not ‘verified’ since 2010 but the completion dates are either in 2011 or later. Your spreadsheet has 7 trials listed from the clinicaltrials.org database. What factor am I not considering such that your total is lower?

thanks again,
Leeza Rodriguez

Reply

Alexey Bersenev June 2, 2012 at 1:34 am

Leeza,
Thank you for feedback!
1. I roughly divide all trials on “stem” and “non-stem”. “Stem” cell types included:
embryonic stem cells,
multipotent mesenchymal stromal cells,
hematopoietic stem/ progenitor cells,
cardiac stem/ progenitor cells,
neural stem cells,
CD133+ cells.
total = 73 (+ 2 trials that I missed: menstrual blood MSC = 75)

From your list I excluded:
BM MNC,
cord blood,
sclerocorneal progenitors,
total BM concentrate

I may re-consider eye progenitors as “stem cells”.
So, depends how I count I can get 73 or 75 “stem trials”. Disadvantage – it’s loosely defined category. But conclusion the same – roughly 50% of cell therapy trials.

2. The difference in number because you count a total number of trials in all time, but i refined my search by 2011 only. As I said, i gave a snap shot of trials registered in only in one year – 2011. So, in my count “adipose stem cell” trials include:
adipose SC = 6 (3 in NIH database, 3 in others)
adipose MSC = 4 (all in NIH database)
total = 10
This year i was able to track 3 so far.

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Leeza Rodriguez June 2, 2012 at 2:06 am

hi Alexey!
So here we are at 10P on a Friday night talking about stem cells!

1. BM MNC — how do we know it’s not the MSC’s in the MNC that are doing the action? Isn’t this on the fine line for “stem cell” ? or no?
Suggestion: on your spreadsheet could you add a column to label each trial as stem cell or non stem cell?

2. OK– I understand. Thank you for clarifying. I am doing a G spreadsheet for the 68 all time search results for adipose stem cells. Working on that now! I should have something within a week. Thanks for turning me on to this !

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Alexey Bersenev June 2, 2012 at 4:56 am

We don’t know and the authors of the studies also don’t know. Nobody knows, but some guys put “stem cell therapy”, some just “cell therapy”, some “MSC” under “total marrow MNC”. We can’t filter it.
Thanks for suggestion, I’d add.

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Leeza Rodriguez June 2, 2012 at 2:13 am

Oh! –one more question….

You distinguished between adipose MSC and adipose SC. Since adipose MSCs are a type of adipose SC, what are other types of adipose SC? Should these be two separate categories?

thank you!
leeza

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Alexey Bersenev June 2, 2012 at 5:00 am

I think I just copied what was written in trial description. Some indicate “adipose stem cells”, some “adipose MSC”. But I’d agree that it’s the same thing, since nobody knows how to purify and use therapeutically other stem cell populations from fat. I may combine it under “adipose SC”.

What is really important to distinguish is fresh SVF (devices trials) versus cultured “adipose SC”, because it’s completely different things.

I’m still not sure should I distinguish myself or just copy what description says. Hand-coded work is hard.

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Leeza Rodriguez June 4, 2012 at 3:58 pm

hi Alexey,

For my own adipose CT spreadsheet, I keep columns of virgin data and then create color coded columns with my designated categories. This way you can always go back to the virgin data column if necessary. I do think it helpful to create consolidated categories so that pie charts are more meaningful.

Looking at things from the practice of medicine side , I think in terms of ’tissue source’. So, if you could collapse some categories to show a Top Level Categories of all stem cell trials in terms of tissue source- ESC, umbilical cord, bone marrow, adipose, etc.. You have it displayed for MSC, but what about the top level view of all SCs? Just my .02.

I’m close to posting my initial findings. Just a heads up that my search results from clinicaltrials.gov show that in 2011 one sponsor registered 10 clinical trials using SVF. Since 2004, I see a total of 54 registered trials, 27 of which are recruiting now. I did do the SVF vs culture expansion allocations. I plan to slice and dice them even further by indication. I am happy to share my G spreadsheet with you. I have formatted it so that it is quite compatible with yours.

Back in a little bit….

LR

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Leeza Rodriguez June 4, 2012 at 5:25 pm
Leeza Rodriguez June 19, 2012 at 4:40 pm

hi Alexey,

My next data set focuses on donor source for adipose stem cell clinical trials. I am trying to present one finding a week, but it seems my day job gets in the way! (At the moment we are doing some major updates to our own website, so I have been held hostage in Google WMT.)

Autologous vs. Allogeneic Adipose Stem Cell Trials:
http://www.cosmeticsurg.net/blog/2012/06/19/adipose-stem-cell-clinical-trials-by-donor-source/

Your comments and suggestions are always welcomed!

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Leeza Rodriguez August 14, 2012 at 1:18 pm

Hi Alexey,
Here are follow up blog posts from my Adipose Stem Cell Trial Database:

part 3: Adipose Stem Cell Clinical Trials by Country- Spain Dominates
http://www.cosmeticsurg.net/blog/2012/07/03/adipose-stem-cell-clinical-trials-by-country-spain-dominates/

part 4: Adipose Stem Cell Clinical Trial Update- August 2012
http://www.cosmeticsurg.net/blog/2012/08/13/adipose-stem-cell-clinical-trial-update-august-2012-part-4/

Remember that my audience targets ~the general population, so it is a little watered down. Again, thanks for the inspiration in prompting me to start this project back in May.

:)
Leeza

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