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comment_35124

Does anyone prepare PRP for tendonitis, OA etc..?

If so, how do you validate the product?

and can you advise a good reference?

Thank you

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  • I am sorry. I did not have the researcher's CV handy. He is an orthopedic surgeon and researcher, not a sales rep. Platelet Gel got a bad reputation when banked blood was used. And, then some tri

comment_35126

Validating PRP is an arduos procedure. Basically it involves validating your centrifuge speed/times. You need to know the donor plt ct and calculate the harvest for maximum yield. Check out the AABB Technical Manual - appendices. Good luck. . . . and NO, don't make PRP - never heard of it for tendonitis.

  • Author
comment_35129

Tendonitis or tendinitis, Osteo-Arthritis, Tennis Elbow, they are now injecting PRP instead of steroids and anti-inflammatory or in conjuction with anti-inflammatory. It seems Tiger Woods and Rafa Nadal the tennis player are treated with it. I was asked today if I would prepare it, I said it needs approval etc... Its a long procedure to get approval. So I am searching to see if it is a Standard of Care before I venture into the approvals, getting a code, writing the SOP and then preparing it. It is autologous prp. and one braws 60mL of whole blood and prepares it on the spot.

What do I collect 60mL in?? What do I centrifuge it in?? I have WB and small tube centrifuges..

I will read the Technical Manual before I ask more questions.

Thanks

Liz

comment_35134

I can see how Rafa Nadal got tennis elbow, but surely Tiger Woods would have got golfer's gout!!!!!!!!!!

:ignore::ignore::ignore::ignore::ignore:

SORRY ABOUT THAT!!!!! I'll go and hide somewhere.

  • Author
comment_35135

hahhahahahahahhaha "Go and hide" you say, don't we all feel like that at times after saying something :omg: hahhaa

Ok, Yes, go and hide, I did not use the plural for tennis player; yet both Rafa and Tiger got injected in their injured kneees.

No WAIT, don't hide, Malcolm you can stay because you certainly do provide comic relief!!!!!!!!!!!!! :giggle: :giggle: :giggle: :giggle:

:thanks: :thanks: :thanks: :thanks:

comment_35156

Back to the subject at hand...our perioperative department makes autologous PRP during surgeries for various uses, but we have never done it for outpatient injections.

I guess you could collect the blood in tubes and combine the plasma after removing the red cells. That way you could spin it in your existing centrifuges (assuming they meet the speed requirements).

Malcolm, you certainly make wild swings from being a hero to being comic relief...it is almost dizzying!

  • Author
comment_35167

Thank you Adiescast, do you have a procedure? The tubes must be sterile obviously and I would collect several tubes, I read between 30 to 6o mL. Should I transfer under a hood? We do not work with tubes at the Blood Bank but we do at the Stem Cell Processing lab.

Thank you

Liz

  • Author
comment_35182

The purported benefit of injecting PRP is that the autologous growth factors contained in the concentrated platelets speed the healing of bone or soft tissue.

comment_35217

Our Sports and Ortho department purchased their own PRP system. I was kept out of the equation because, hey, I'm a blood banker, what do I know. I have seen it ...there are several systems available. I think they have the Cytomedix

Sorry, it scares me.... There was a blurb about it in this months AABB magazine. Should have some oversite as far as I'm concerned. But hey, we blood bankers want to control everything about blood products.

comment_35370

We have a contractor that makes it in our OR for the surgery patients. We have nothing to do with it in the BB. It is the same contractor that provides the perfusionists and I think they have a special machine for it. When we got our new BRATs for cell salvage they tried to market them as making PRP but I don't think they are very efficient for that use. I have heard of it being used for OP joints but don't know quite how they are doing it. Try searching in Orthopedic journals--or Pub Med. The daughter of on of my BB staff works for the contractor making PRP. I could probably ask her to find out what machine she uses.

Edited by Mabel Adams

  • Author
comment_35374

Dear Mabel,

Thank you for your reply, yes I would appreciate it if you could ask her the brand name of the machine and if she is pleased with it. Is the machine FDA approved and is the actual procedure FDA approved, or does it not need approval.

Thank you very much.

Liz

comment_35377

Don't get involved with this! How are you going to label it? How are you going to manufacture it with out contaminating it? How do you assure it goes back to the correct patient? We used to store a product for our wound care center made out of platlets. Eventually the FDA closed down the lab that made it for precisely these reasons.

There are machines that makes PRP. It is a closed system. Performed at the bedside. I was just talking to a perfusionist on monday about this. They are a contractor. They were asked to make PRP for a surgical case. They brought in a machine. There are several out there.

http://www.perfusion.com/perfusion/prpdevicesummary.asp

Point of care is the way to go!

J

comment_35380

We use it at our facility for numerous orthopedic surgeries. It is performed by the OR staff and it's called the GPS system (gravitational platelet system). I believe the original work was done in California probably 10 years ago involving injections of platelet concentrates into subjects with tennis elbow. Supposedly the cure rate was around 70%. I have no idea what kind of validation the OR did or if they just started using it based on published data. I'm glad that it's THEIR procedure and not mine.

Don

comment_35385

Apparently it has been done in Europe for 20 yrs. It sounds like some applications have FDA approval, though as far as I could tell it is not yet approved for tendonitis (though my reference may be out of date on that). When I checked into it about 6 months ago, I found lots of ortho practices advertising it as an office procedure. It was not something that our orthos were doing in Surg (yet), but if they decide to go ahead with it, I'm sure I would be about the last to know. :confused:

comment_35387

It is an autologous product. Would not use donor platelets. That is why point of care is preferred. Machines are manufactured that way.

J

PS: the product made from platelets years ago for wound healing was called "procuren".

  • Author
comment_35421

Thank you all for the valuable information and opinions. I am not so excited about because I agree that it should be a point of care treatment, as a mix-up can occur...... but then I think that I am issuing BLOOD! So if I can do that, the PRP should be within my spectrum of what is "possible" for the BB.... still thinking about it.

Thank you

Liz

comment_35443

PRP (Platelet rich plasma) is very rich in growth hormone factors and has been used for a lot of orthopedic surgeries and at the dental office after bone graft.

It's latest use is in cosmetic skin rejuvination , believe it or not but there are some dermatologist in New York using it instead of botox and it looks very promising.

A company called Harvest which is based in Plymouth Ma, makes special centrifuges and collection tubes and is FDA approved for harvesting the PRP for orthopedic and dental surgery.

Harvest is being sold to Terumo therefore we might see the practice shifting to the blood bank to prepare the PRP.

  • Author
comment_35467

For those who know Doctors or Medical Centers who perform PRP for Sports Medicine, do you have an idea how many a year are performed?

I am told I would have to prepare 200 a year. Is this a low, high or normal number? I am wondering because I have to justify investing in the machine.

Thanks

comment_35484

Why do they want you to prepare the PRP? This PRP injection is different than the stuff the BB prepares from donor platelets for infusion. You essentially would be preparing a drug. You would not need a FDA license? What would the FDA inspector do if he saw you prepare this product in your non-clean room blood bank? How would you label and store it? How would you assure that it gets back to the patient it came from? A really big deal when you think about it-patient A getting patient B's product. Would you perform the same tests as a we would for blood donors? How would you bill for it? You would want to get the $$ back that you invested in the machine you bought to make it. Think about tech training! This is best left in the doctors office as a point of care procedure. Our outside contractor perfusionists got involved in this and brought in the machine their group owns. The sports medicine program needs to invest their money andtake ownership of this non approved procedure and product.

j

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