A Fresh Look at Stem Cell Therapy
A fresh look at stem cell therapy; you may be both surprised and enlightened when you find out how regulations have changed for cellular based products.
These cells are one of the essential building blocks of life. They have the unique ability to grow into a variety of other specialized cells, forming brain, muscle, and internal organ tissues during the development of a fetus in the womb. Following conception, stem cells either remain as stem cells or transform into the types of cells the body needs to grow. In some parts of the body such as the bone marrow, stem cells continue to replenish the tissues throughout the lifespan, while in others such as the liver, they will only reproduce under specific circumstances.
What can they be used for?
While many claims have been made about the possible role of stem cells the most common ones include regenerative medicine techniques for the musculoskeletal system. As they have promoted to have healing and regenerative properties, stem cells have been used to enhance repair and renewal of tissues affected by musculoskeletal pain due to osteoarthritis, muscle, tendon and ligament injuries. The pain of arthritis is caused by the wearing away of the cartilage between bones that allows joints to move freely. There are studies that show that stem cells encourage the regrowth of cartilage in many patients, typically offering 50% relief in 80% or 80% relief in 50% of patients. The therapy has also been proven effective in the treatment of certain cases of peripheral arterial disease that causes the build-up of fatty deposits in the arteries, restricting blood flow to the legs. In addition, stem cell injections have been shown to increase wound healing rates and even reverse complex conditions such as reflex sympathetic dystrophy (RSD) or complex regional pain syndrome (CRPS).
It should also be noted that due to concerns surrounding over use, or excessive claims regarding stem cells, in July of 2020 the FDA released new guidance however discouraging the use of Stem Cells as a label for treatment. As part of this regulatory change, the FDA issued stricter requirements and stronger enforcement for premarket approval claims by manufacturers of human cellular or tissue based products (HCT/Ps).
Most adult stem cells are taken from the bone marrow and body fat. Bone marrow is most suitable for patients under the age of 45, but fat cells can be used at any age. Bone marrow cells are used in certain kind of cancer treatments. Fat cells are more like and similar to structural support cells. Today, without specific Investigations Drug trial status (IND), manufacturers of umbilical cord derived stem cells taken from during the delivery of healthy new-born babies can no longer make claims that they are providing stem cells. We have been advised that regulations do allow, however, for claims of nanoparticle technology derived products. Umbilical cord and placental derived products are typically discarded after the birth, but since it’ is believed that they contain high levels of molecules related to tissue generation (growth factors) they are an ideal source of the same for treatment purposes. Umbilical cord derived products have no impact upon the mother or baby so those with ethical concerns have nothing to worry about. One big bonus of using umbilical derived products is that no harvesting from your own tissue (that means no surgery) is required. As there is no need for cells to be harvested from your own body, you simply attend an outpatient clinic to have the HCT/Ps applied. Easier to administer, less physical trauma to you, and lower cost without sacrificing out-come can make these products a great option to consider.
At Piedmont Physical Medicine and Rehabilitation, we tell about 50% of the patients that come to us asking for stem cell treatment that they don’t need it. While HCT/Ps are a great treatment option if we can take care of your condition without going to the expense of using them then we will recommend that instead. In those cases that do need an HCT/P or structural support cell approach, about 50% the time we will also add PRP (Platelet Rich Plasma), which adds growth activating factors to boost the effectiveness of the treatment. This may be done either at the time the products or support cells are applied, or several weeks later. If we feel that an additional boost it needed to provide the best outcome then we will recommend PRP as well. Post application we also will do whatever is needed to make sure you have a successful outcome. We are holistically inclined and see our role as going beyond just providing you with regenerative medicine techniques.
You might wonder if it’s uncomfortable, for the most part, don’t. The procedures are performed on an outpatient basis. In those cases that do experience mild discomfort, the pain can be controlled with over-the-counter painkillers. Many patients experience an improvement in the condition within 2-3 weeks of application but in in other cases it can take as long as 3-6 months until full benefit is realized. If you’re living with the misery of musculoskeletal pain, these therapies are well worth considering. You can discuss this and other potential treatment options with the experts at Piedmont Physical Medicine & Rehabilitation, where we are committed to finding the best treatments for you and your chronic pain.