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Korea number 2 for Stem-Cell trials

US, top seated more than 135 cases

Leslie Chang (leslie@pharmnews.co.kr) 다른기사보기 

2015-04-08 오전 9:32 페이스북 트윗터 kakao 목록 보기 프린트

Domestic Pharm Co's are the 2nd placed in the step-cell active clinical trials followed by the US.

Recently, MFDS has issued the analysis report on Stem-Cell and its Regulation Trends on 7th April, including the analysis on clinical trials by countries, symptoms et al.

Over 277 trial cases that are listed in US (www.clinicaltrials.gov) among 1,215 different study themes, the report showed - Number of trials by country, Categorized illness and types of stem-cell analysis. 277 cases are the ones approved by the authority so that the test-body can freely perform the trial.

Any trial carrying out in US must be registered but other region may not have to register the trials. For the reference, there were 50 cases under the name of stem-cell related trials in Korea as of March 2015.

Trials by Country

From 1998 to 2014, the number of trials are dominantly by US - 135 cases (49%). Korea 39, China 25, Spain 21 and Germany, Panama for each 7, England, Malaysia 4 each and lastly 1 case by Japan.

Among these countries, US, Korea, China and Spain has more 1/2-phase simultaneous trials than separate 1st and 2nd phase of trial to save the time.

US has showed 124 cases of initial phase of trial and 11 cases of epilogue trials. (2/3 and Phase-III)

Korea has 33 cases of initial phases and 6 cases of the epilogue trials, other than those categorized ones, Korea is currently carrying out the 38 different cases of Stem-Cell related trials.

If only focused on last year, 47 new trials were kicked in globally and US has far more cases - 16, followed by China 10 and Korea 5.

Categorized by disease

If we look into the categorized disease trials, there are - 51 Cardiac related cases, 48 Neuron related cases, 29 cases of orthopedics, 26 cases of alimentary, 21 cases of immune system, 20 cases of Cancer related, 20 cases of blood vessel and 12 cases of ophthalmology.

Among these trials, Korea is currently carrying out 9 cases of neurons and 6 cases of alimentary and 5 cases of orthopedics and 3 cases of cancerous disease. While only 2 cases of cardiac related trials unusually cardio trials are commonly tested out in other region.

In the case of US, cardiac related trials are the most common over 39 cases, followed by 22 cases of neuron, 13 by Cancer, 10 by blood vessel and 8 cases of alimentary. Newly initiated from the last year was 11 cases of neuron, 6 by immune system and 6 cases for blood vessel and 5 for cardiacs.

Among the tests, mesenchymal cells that can be cell-differentiated to a certain cell was the most commonly used approach (190 cases) and 35 cases of using hematopoetic stem cell, 11 cases for neuron stem-cell.

The case of using the homeopathic origin stem-cell that uses a different organ's cell were 147 cases that was bigger than the case of 130 which uses the self-oriented cells. This can be compiled as this approach would be easier for the mass production and it reflected it on the trial.

NIFDE(National Institute of Food and Drug Safety Evaluation) has stated that the report would be very helpful in the perspective of conceiving the current stem-cell related R&D and its activities and the Institute would continuously provide the related information pertaining to the regulations as well as the system that supports the stem-cell R&D.
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