Amniotic Membrane Allografts for Joint Pain Relief

Have you heard of amniotic membrane allografts for treating joint pain?

Many people deal with pain in their joints, especially athletes and those who have achieved longer lives. Osteoarthritis is a leading cause of joint pain, and until now treatment was mainly palliative, as the joints cannot repair themselves and science did not have a way of curing the underlying problem. Therefore, patients have found looking for joint pain relief a never-ending battle of frustration. However, new treatments using birth tissues have become possible, suggesting that pain and OA can be treated once and for all.

What is osteoarthritis?

Our joints have cartilage, which provides a surface that allows the joints to move smoothly. It is a firm, rubbery material. The cartilage also acts as a cushion between the bones so that they do not rub together.

Around 27 million Americans deal with osteoarthritis, often in knees, hips, lower back and neck, and in the fingers. With this condition, which is degenerative, the cartilage breaks down. Patients have pain, swelling, and trouble moving.

According to www.arthritis.org, 1 in 2 adults will develop symptoms of osteoarthritis in their knee during their lives, 1 in 4 will have hip OA by 85, and currently, 1 in 12 people 60 and up have hand OA.

OA can cause additional problems, whether from lack of movement, or from conditions such as bone spurs, the technical term for which is osteophytes. Bone spurs are caused by the body trying to repair loss of cartilage, whether from OA, injuries, overuse, genes, obesity, or other causes.  They are often first diagnosed with an x-ray for another cause. For some people, bone spurs make moving the leg painful, and may cause a change in mobility. If the bone spur presses on nerves, it can cause weakness, numbness, or tingling. Other symptoms may include muscle spasms, cramps, or weakness. Bone spurs may not cause any symptoms in some people, but they can cause inflammation and the production of other elements that cause a cycle of damage to the cartilage.

How can birth tissues such as amniotic membrane allografts help with joint pain relief?

Birth tissues might be used in a variety of clinical procedures. One such application is using amniotic membrane tissue for joint pain. The amniotic membrane is a layer of cells, called an epithelium, on a basement membrane, on top of an avascular layer called the stromal layer. The membrane has hyaluronic acid, and growth factors.

The tissue is allografted—that is, taken from a consensual donor to the clinical patient. Amniotic membranes are for homologous use only per the FDA, meaning the cells and tissues perform the same basic function in the donor as in the recipient. Pain relief for joint pain comes from the protective cushion that is provided for damaged soft tissues such as joints or cartilage.

The benefit of amniotic membrane tissue allografts is that they can be used very precisely, and the amniotic membrane has both antibacterial and pain reduction properties. The material is cryopreserved and often injected in a noninvasive procedure, as opposed to the multiple surgeries often required with other treatments. The benefit of cryopreservation is that it preserves the hyaluronic acid, a clear substance that retains water and keeps tissues lubricated; growth factors; and collagen. The amniotic cells can differentiate into several different kinds of cells, including osteogenic. There has never been evidence of immunologic rejection that one might fear in an organ transplant, and anti-rejection drugs are not needed.

Amniotic membrane allografts for joint pain relief need only be performed once, as opposed to steroid shots that do not cure but only provide temporary relief and must be repeated regularly. In some cases, the procedure time is only 15 minutes.

FDA guidelines and what to look for

As required by the FDA, a reputable clinic will use materials from patients who are pre-screened for risk factors, contaminants, and infections. The amniotic membrane should be thoroughly tested for a number of pathogens, bacterial and fungal, to provide a clean, safe graft. Look for doctors who will provide amniotic membrane tissue for joint repair who can provide evidence of extensive testing.

The FDA requires that structural tissues, those including materials that cushion or connect (in this case amniotic membrane), must be minimally manipulated. For structural tissue such as amniotic membrane, processing cannot alter the original relevant characteristics of the tissue relating the tissue’s utility for reconstruction, repair, or replacement. FDA guidance memos suggest processing is any activity other than recovery, screening, testing, storage, labeling, packaging, and distribution.

There are many considerations in amniotic membranes: controlling communicable disease; preventing contamination, preserving the “integrity and function so that the products will work as they are intended;” and making sure safety and efficacy and be assured. Relief for joint pain should be both effective and safe for all parties.

The FDA also requires that the tissue, with some exceptions, cannot be combined with another article. In the case of joint repair, the tissue cannot have a systemic effect, and cannot be dependent upon living cells.

Conclusion

Millions live with joint pain every year, often from osteoarthristis. Amniotic membrane for joint pain can relieve this pain. Look for providers who follow FDA regulations and guidelines to make sure you will receive relief from joint pain that is safe and effective.

By Jessie A. Arnold, JD, MA, Legal Advisor

References

https://www.fda.gov/media/124138/download
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6307525/
Previous Article