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Thread: New PRP Study

  1. #1
    IAHRS Recommended Hair Transplant Surgeon John P. Cole, MD's Avatar
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    Default New PRP Study

    I need to enroll patients in a new PRP study using the Emcyte PRP kit and protocol.

    The study will involve treatment only in a small portion of the crown (4 square centimeters) either with PRP and microneedling or with saline and microneedling. You will not get treatment to the entire area of hair loss and you may get a placebo plus microneedling rather than PRP. You will not know which you receive, PRP or saline.

    Patient follow-up is every 6 weeks for 52 weeks. we will measure hair density and hair mass at the beginning, 36 weeks, six months, and one year. Hair density will be measured by trimming hair.

    Here are the inclusion criteria and exclusion criteria. This is an IRB multicenter study to evaluate not activated neutrophile poor PRP at 5-6 times concentration of platelets.

    If you would like to participate in this study, please contact us at consults@forhair.com

    "Inclusion Criteria."
    "Subjects eligible for enrollment in the study must meet all of the following criteria:
    1) Male with Norwood 3v, 4, or 5 androgenetic alopecia
    2) At least 18 years old at time of study
    3) Severity
    Male: AGA classified as type 3 vertex, 4 or 5 utilizing Norwood-Hamilton classification diagnosed by history, physical examination, and either biopsy strong family history of androgenetic alopecia
    4) Willing to comply with study requirements: including maintaining the same hair color and hairstyle throughout the study and not using alternate hair los treatments, such as finasteride, minoxidil or LLLT.
    Exclusion Criteria."
    "1) Younger than 18 years of age,
    2) Medical conditions exclusion
    a. History of abnormal thyroid conditions
    b. Any unstable serious co-existing medical conditions
    c. History or current evidence of any serious and/or unstable pre-existing medical or psychiatric disorder, in the opinion of the investigator
    d. Current active systemic infection, or cancer
    e. Current active use of anti-inflammatory drugs (NSAIDís, should be stopped 4 days before the blood draw)
    f. Known platelet dysfunction syndrome
    g. Patients on blood thinners
    3) Hair and scalp disorders exclusion
    a. History of hair transplantation in the treatment area"
    "b. History of hair loss other than AGA including Autoimmune diseases (i.e. Lupus, Rheumatoid Arthritis, etc.), scaring alopecias, traumatic alopecias, and trilotichomania
    c. Use of any product aimed at improving or correcting the signs of hair loss within 60 days of the start of the first treatment
    o Use of light or laser treatment of scalp
    o Use of dutasteride
    o Use of finasteride
    o Use of minoxidil (oral/topical)
    o Use of drugs that will affect hair growth
    d. Having a scalp skin disease at the area of treatment
    4) History of allergy to lidocaine
    5) History of use of steroids (i.e. prednisone, methylprednisolone, etc) that could interfere with the effectiveness of the NP-PRP, within the last 3 weeks."
    John Cole, MD
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  2. #2
    Senior Member JJacobs152's Avatar
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    Default

    Great opportunity for patients to enroll in a true double-blinded prospective study to see the efficacy of PRP. I would jump on this but currently taking finasteride and topical minoxidil.

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    Default Essay

    It is a very tricky business as it involves a lot of legalities. Find an expert on https://github.com/stevemajestic/maj...criptive-Essay who can answer tyour question better.

  4. #4
    IAHRS Recommended Hair Transplant Surgeon John P. Cole, MD's Avatar
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    Default

    Quote Originally Posted by JJacobs152 View Post
    Great opportunity for patients to enroll in a true double-blinded prospective study to see the efficacy of PRP. I would jump on this but currently taking finasteride and topical minoxidil.
    It's a good study; it's not easy to talk patients into this study since it is really double-blinded and placebo-controlled combined with a very small treatment area.
    John Cole, MD
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    I'd be first on line if this wasn't a double blind placebo controlled study.

    Next time!

  6. #6
    IAHRS Recommended Hair Transplant Surgeon John P. Cole, MD's Avatar
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    I hear you mitcky! To be honest, this is a great study and the sort of study we need. It's just very difficult to encourage patient participation. No one with hair loss wants to wait a year to find out if they got placebo or treatment. Plus, we are treating only 4 square centimeters. The inclusion category is patients with NW 3V, 4, and 5, which means you have 70 to 180 square centimeters of thinning or loss. No one wants to treat only 4 square centimeters when they are losing hair. I signed on to participate in the study, but I have a very difficult time procuring patients due to the inclusion categories and the double-blinded nature of the study. I've published papers comparing PRP on one side to PRP with Acell on the other side along with different types of PRP on each side, which it is easy to find patients to participate in. Placebo-controlled studies are not as easy to find patients. I can't blame patients for refusing to participate in this one.
    John Cole, MD
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    Doc- In your experience, does this PRP work? Does it work with Acell?

    Any reading you can recommend? Thanks

  8. #8
    IAHRS Recommended Hair Transplant Surgeon John P. Cole, MD's Avatar
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    There is good PRP and not so good PRP. There are some that make very inexpensive PRP that does nothing. There are in between PRPs that do something, but not as much as other PRP kits. Each kit is a little different. I believe it has something to do with the quality of the platelets that are captured. Some physicians simply spin a speckled top tube and make PRP from it. This is going to do nothing. Others use a variety of kits. Some kits are better than others in terms of growth factor concentrations and results. For example, Regen is popular but results in a 25% decrease in density at 6 months, whereas Angel produces a 50% increase in density at 6 months.

    Then there is a question of visible results. Once miniaturization has reached a certain degree, increasing density does not improve coverage. While there is an improvement in hair diameter with good PRP, there is not much we can do with advanced hair loss or a bald scalp with even the best possible PRP preparations. The most optimal time to start PRP is when your hair loss is early. If you wait for hair loss to advance, you will not see as much of a result. Unfortunately, when you start early, you also don't see as much result because you don't have much hair loss.

    Does this lead us into the issue of what does PRP do? Good PRP helps to slow the aging process of hair. Thus, you want to start early on PRP and continue it. PRP induces anagen or the growth phase of hair so you want to use it. You always want to keep hair in anagen because inflammation starts in the resting phase. It is the inflammation that destroys stem cells and eventually prevents the hair follicle from returning to growth following the resting phase. PRP is anti-aging medicine.

    Adding Acell to PRP does result in more hair density than PRP without Acell. I wanted to study this because I began adding Acell to PRP in 2008 and the world followed. I felt I had the responsibility to perform the study. The new thing is to add the amniotic membrane to the PRP. This should be even better.
    John Cole, MD
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  9. #9
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    Thanks for the detailed response. A little depressing as I'm 63 and hate losing hair.

    Oh well--the search continues.

    Again, thanks.

  10. #10
    IAHRS Recommended Hair Transplant Surgeon John P. Cole, MD's Avatar
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    You might consider topical finasteride combined with topical minoxidil once a day. This is a great hair loss grower. It's the best medical product I've come across to grow hair.

    PRP is a fantastic anti-aging therapeutic. The key to any anti-aging regimen is to start on it as early in life as possible and stay on it. Anti-aging is designed to keep you looking and feeling younger as you mature. Wouldn't it be nice to look and feel 50 when you are 90? It is never too late to start though.
    John Cole, MD
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