badge CLINICAL PHARMACOLOGIST AND THOUGHTS OF A DOCTOR: TCS-PGI SYMPOSIUM

Thursday, August 27, 2015

TCS-PGI SYMPOSIUM

TCS-PGI SYMPOSIUM
Reporting from the symposium. Important excerpts from the symposium

DATA IN SUPPORT OF THE CLINICAL USE OF ADIPOSE DERIVED MSC: GROWTH, STORAGE, FUNCTION AND SAFETY

WILLIAM A FAUBION MD
ALLAN B DIETZ Ph.D.

1.     GLP certified Phase 1 trial on the Adipose MSC on the undertaken currently.
2.     There are variety of products for which these Adipose MSC can be used like ALS, MSA, ARAS, Anal fistula, Crohn disease.
3.     Cells therapy are drugs. So it should be as much stable, reproducible and safe.
4.     They have patented a technology known as 5%PLTmax for developing stem cells which can be used with the properties which was mentioned in point 3.
5.     MSC can differentiate into Bone, Cartilage.
6.     The stem cells maintain their viability even when passed through various needles, and the population doubling is independent and not affected by frozen. This was proved.
7.     Safety issue? Tumour, how will it migrate, is it efficacious in the disease specified
8.     For testing the malignant transformation SCID mice is used, as the immunity should not interfere with the malignant transformation.
9.     On very high concentration of MSC, then also tumour did not form but increase collagen was formed
10.  The same high concentration MSC was injected intrathecal, intrarenal. These high concentration was purposefully injected to see for the potential of malignant transformation.
11.  For safety you have to test biometrics (measure the weight), all major organ pathology, study the behaviour and you have administered the MSC as mentioned in the point 9 and 10.
12.  Other important points to note in this preclinical study is that more than 70 animals used, 3 species, different route of injection
13.  EXCITING POINT: In ovarian tumour the stem cell is used as a Trojan war horse which carries the oncolytic virus to the ovarian cancer
14.  CONCLUSION: Don’t put the product in the patient untill all the technology is clearly understood. When a survey was undertaken, patient was preferring autologous over allogenate.

STEM CELLS IN POST SURGICAL GASTROINTESTINAL LEAK
NAVTEJ S BUTTAR MD
1.     Over 10 lakh gastrointestinal surgeries are done per year. So gastrointestinal leak is a common programme and there needs to be new good treatment for the same.
2.     Over Macro and Micro level changes are responsible for the gastrointestinal fistula.
3.     The micro level changes which are responsible is inflammation and Macro level changes are Age, obesity.
4.     Currently drain are used. Scaffold for filling the space is an important factor.
5.     This stem cells will not be used for fresh 2-3 day fistula, over these we use OTSC placement. These stem cells are mainly used for old fistula very difficult to treat.
6.     IDEA CAME FROM: Graham’s idea of using fat for the closure of the ulcer is used hear for the closure of the big fistula in the gut.
7.     With this idea of using adipose tissue for closing, the same logic was used for giving Matrix loaded SMC for closing the large fistula which are resistant to other treatment.
8.     STEMMIX TRIAL IN POST SURGICAL FISTULA is undertaken currently in the world.


AUTOLOGOUS MSC THERAPY OF PERIANAL FISTULIZING CROHN DISEASE
WILLIAM A FAUBION MD

1.     Form a treatment and research team around a patient problem. The inputs which these two teams will give a lot of translational potential.
2.     PROBLEM ATATEMENT: 1 perianal fistula occurred in 33 % of Crohns disease
60% of the patient does not respond to medical therapy. Available treatment is ineffective. Morbidity is significantly
3.     CURRENT THERAPY: Treatment of patient with Fibrin glue was one of the novel approaches but it is ineffective.
4.     Stem cells used for perianal fistula around the world.
5.     So this trial consists of
Seton placement, control of sepsis
After 6 weeks the Seton are removed the Mesenchymal loaded fistula plug is replaced in the place and fixed to fill it.
6.     Healing per drainage cessation was used for assessing the effectiveness of the treatment and Likert scale was used for evaluating it.
7.     Out of 9 patients who were evaluated untill now 8 patients have resolved and the problem recurred. But in one patient there is recurrence.
8.     EXCITING POINTS: In Bioengineering there are a list of compounds which can be used in humans what are those. These are important to use in research.
9.     Mesenchymal stem cells have immunomodualtory properties.


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