Stem Cells, Friend or Foe?

in stem •  6 years ago 

Stem Cells For Arthritis. Does it really work?

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Osteoarthritis (wear and tear arthritis) plagues millions of Americans.

Osteoarthritis is an inflammatory condition that is initiated by wear and tear on the joints. The knee, hips and base of the thumb are the most common joints involved.

Present treatments include Tylenol, up to 3000mg daily, NSAIDs or antiinflammatories such as ibuprofen or naproxen, oral/injectable steroids, topical NSAIDs like diclofenac, viscous, injectable supplementation such as Synvisc or Hyalgan, acupuncture, tai chi, water therapy, physical therapy and joint replacements.

Here’s the problem; NSAIDs can raise pressure and increase heart disease, steroids can increase pressure and sugar, steroid injections can weaken ligaments, joint replacements can fail and have other side effects and most of these treatments stated above need to be repeated.

So what about stem cells. We already employ stem cells in our own bodies to repair most tissues. If you break a bone, then your own stem cells differentiate into bone producing cells called osteoblasts and the bone is repaired. If we harvest stem cells from our own body, then they can be reinjected into our knees, for example, to help with pain and disability. This is called autologous donation.

Does it really work?

Maybe. Like arthroscopy and other procedures, the placebo effect is quite high. According to Exp Ther Med. 2016; 12(5):3390-3400 (ISSN: 1792-0981), the effectiveness of stem cells was significant in relieving pain and improving functional status in the knee up to at least 2 years. Increasing the numbers of stem cells didn’t matter even though it did matter in previous studies.

Please know that the quality of the studies is not great and we need more randomized, controlled, double blinded studies to determine the truth but progress has been made. The following is a review of several studies published in 2018 with the corresponding conclusion:

Arthroscopy. 2018 Nov 16

Intra-articular Mesenchymal Stem Cells in Osteoarthritis of the Knee: A Systematic Review of Clinical Outcomes and Evidence of Cartilage Repair.
Ha CW1, Park YB2, Kim SH3, Lee HJ3.

CONCLUSION

Intra-articular MSCs provide improvements in pain and function in knee osteoarthritis at short-term follow-up (<28 months) in many cases. Some efficacy has been shown of MSCs for cartilage repair in osteoarthritis; however, the evidence of efficacy of intra-articular MSCs on both clinical outcomes and cartilage repair remains limited.

Maybe it is all just placebo, right?

Arthroscopy, according to 2 studies, doesn’t work any better than sham arthroscopy in both the young and elderly. There are exceptions but my main point is that arthroscopy is a powerful placebo. Stem cell harvesting and ultrasound guided injections may also have a strong placebo effect. Still, my bias is that stem cell replacement will eventually supplant many orthopedic surgical procedures. Currently, small randomized controlled trials show efficacy.

How much does it cost?

The costs vary and can range from 3000-6000 dollars a joint. Stem cells have been injected into the back, hips, knees, shoulders, other joints and tendons.

Be aware that there are many fraudulent companies out there because the costs for the procedure is expensive and insurance hardly ever reimburses. This is a money maker. On the other hand, legitimate companies do exist as well.

Where should I go?

Many of these companies are scam artists and are breaking the law. Here is one reasonable suggestion:

Consider Regenexx since they have done 50% of the researching the field, have the research laboratories, and have been in business the longest (since 2004). They have also conducted safety studies and found that stem cell replacement to be fairly safe for orthopedic procedures.

I have no financial or scientific association with any stem cell firm. My desire is to be transparent and helpful in a very complex field.

What stem cells work the best?

This answer is not completely known. Typically the stem cells are harvested from the fat surrounding your belly and the bone marrow in the back of the pelvis. They can also be collected from your blood. These procedures are relatively easy and involve minimal discomfort.

Are stem cells FDA approved?

No they are not but certain methods are FDA cleared so it is OK for the doc to perform the procedure. The doc just cannot claim that his or her procedure treats any condition.

There are two categories of HCT/P (the abbreviation for human tissue).

One is a 361 product and your doc is allowed to give it without restriction. It includes any product from your own blood and bone marrow. It also includes your own fat with some restrictions.

Docs are only allowed to reinject tissue from yourself, or a first degree relative. Your own stem cells must be injected right after collection. They cannot be allowed to grow for days or weeks.

The second product category is 351 and this means everything else, and any tissue donated from a non 1st degree relative. Umbilical cord blood and amniotic fluid would be 351 products and this necessitates a drug application which requires years of research and millions of dollars. Even if your own stem cells are grown, the FDA deems that to be a drug or a 351 product since your cells are allegedly being manipulated.

Unfortunately amniotic fluid and umbilical cord blood contains very few stem cells or MSC (mesenchymal stem cells). And by the time the company gets the cells, they are almost always dead cells. Companies cannot claim to inject live umbilical cord stem cells, otherwise it is a drug and drug approvals take both time and money.

Therefore you are either receiving dead cells and paying 1000s of dollars for what you thought to be live stem cells OR somehow you are receiving live cells not from your body illegally because such cells are not an FDA approved drug. Apparently, either way you are being scammed.

Cord blood does contain hematopoietic stem cells for bone marrow transplants but these cells are alive and such transplants are approved by the FDA for leukemia and other blood disorders.

Once again, if a company claims to be giving you live umbilical cord stem cells for healing your knee, then that company has broken the law. They are pretending to deliver a drug which has never been approved and you are being scammed.

A company just can’t deliver a foreign substance to you and call it a drug. Once again to get a drug approved by the FDA requires detailed clinical studies, millions of dollars and countless applications. We are emphasizing going legal because many stem cell companies are scam artists because there is a lot of money to be made.

Ok, then why do some patients claim success with dead cells?

Often patients are receiving PRP or platelet rich plasma with the dead stem cells. PRP comes from a special filtrate of your own blood and may actually help with joint pains. This filtrate contains many growth factors with healing properties. Trouble is...many companies are charging thousands of dollars for dead stem cells plus PRP. Usually the PRP only costs a few hundred dollars a joint.

So what should I do?

Avoid the above scam. Have a reputable company harvest your own stem cells and immediately inject you. They should not advertise that the procedure is indicated for any particular condition because your own stem cells are not an FDA approved drug. But they can discuss the pros and cons of the current studies. There are reputable clinics BUT buyer beware.

What about other stem cell projects besides the orthopedic procedures?

Other stem cell projects haven’t fared as well. Homologous (from your own body) stem cells were injected for metastatic breast cancer and proved costly and disastrous.

Homologous stem cells (your own stem cells)were injected into a patient’s kidney who had lupus and he required a nephrectomy due to new tumors in his kidneys.

Homologous fat cells were injected into the back of the eye for the treatment of macular degeneration and the patient went blind.

A patient received stem cells from another person that were injected into his brain due to a stroke. Tumors developed and the subject became paralyzed.

The future, however, does look bright. One day we see joint replacements being replaced by stem cell technology but right now be cautious, investigate and do your research.

Mesenchymal stem cells (from their own fat or bone marrow) have been injected near the spinal cord in ALS and it has been tolerated well. There has been subjective improvement but more studies are needed.

Drs. Rx:

Stem cells are the wave of the future. Discuss this article with your health care provider.Small studies especially with the knees show some efficacy. Beware of the scammers. Actually the stem cell field reminds me of crypto. Many coins are scams but a few are gems including Steem. I hope I’ve opened a few eyes in a complex field that is more like an obstacle course; you can traverse the field but watch out for the mines. Good health to all you Steemers or Stemians and it is a privilege to post. I have so much recent info that I want to pass on. So we’ll see how this post goes. I am also happy to write about areas that interest you.

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Http://DocLipkis.com

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