What Is So Special About Stem Cell Research?

Stem cell research goes back to the 1950s when German biologist, Ernst Haeckel coined the term. In the United States, while working with adult mice, in cancer research in Bar Harbor, Maine, researcher Leroy C Stevens discovered these cells could change into any cell (pluripotency).

By 1998, after 50 years of study and research, scientists learned how to take stem cells from a human embryo and grow them in a laboratory. That became an ethical football. Religious leaders and ethics philosophers rallied the support of politicians to prevent research. They expressed deep concern scientists would encourage the harvesting of the newly-born and unborn to solve adult health problems.

Researchers turned their focus to adult stem cells. While adult cells are not as powerful as embryonic cells, they can be taken from one part of one’s body and used to heal another part in sufficient numbers. Stem cell research continued with a new challenge – overcoming the decreased ability to change into as many other types of cells during development. Hence, the preference for younger stem cells.

Stem cells are attractive to medical professionals because they can heal many diseases caused by the loss or malfunction of cells in our bodies. Since stem cells can match and multiply into other types of cells, we have hope we can reverse diseases we cannot currently cure. Studies are underway in areas of cancer, type-1 diabetes, and chronic lymphocytic leukemia. A more common and successful approach is in healing soft tissue with adult stem cells. Knees, shoulders, wrists, and hands are typical candidates for stem cells in the emerging field of regenerative medicine. 

 How Does It Work?

The following example relates to typical candidates. In this process, the stem cell treatment endorsed by our institute applies stem cells to a three-dimensional network of extracellular macromolecules (ECM Matrix). We use hyaluronic acid (HA) to reproduce the tissue microenvironment. Using HA in a 3D system allows a more dense and compact cellular environment.

The diagram above has six key events.

1. Soft Tissue Injury

After we determine that the cartilage (tendon, ligament or meniscus) has a “partial” tear we begin the treatment plan to regenerate the tissue. This diagnostic step is critical because it helps us make the decision whether we need to recommend surgery (for “complete” tears) as opposed to a more conservative approach using regenerative medicine like stem cell therapy.

2. Stem Cell Treatment Begins

Once the patient is accepted as a candidate for stem cell therapy, we begin by injecting a combination of Extracellular Matrix (ECM), Hyaluronic Acid (HA), Platelet-Rich Plasma (PRP) along with stem cells into the injured joint. This procedure is always done under ultrasound guidance.

3. ECM (PRP+HA) + Stem Cells Scaffolding Built

The combination of Extracellular Matrix (ECM) and Hyaluronic Acid (HA) may work as a scaffold where stem cells can attach and begin to divide and grow.

The Platelet-Rich Plasma (PRP) contains important Growth Factors (GF’s) necessary for the survival, division and growth of the stem cells.

4. Soft Tissue Regeneration Begins

The stem cells begin to actively divide, grow and differentiate along the scaffold into new soft tissue known as cartilage (tendon, ligament or meniscus).

5. Regeneration Complete

The stem cells undergo complete differentiation to become newly regenerated cartilage.

6. Fully Healed Soft Tissue

The previously injured cartilage is now fully healed.

What Is The Controversy About?

 In short, the controversy revolves around the nature of the scientific method. Many doctors and researchers run studies and confirm the findings with colleagues who repeat the methods and find similar conclusions. This group sees the potential to help people now. 

 Other professionals prefer to wait and see the results over a long period of time. They turn away people who may be excellent candidates until the science confirms all possible consequences. This group builds studies and trials under slower and stricter controls with plenty of oversight. 

 A small number of practitioners promote stem cell therapy to build their wealth. 

In the United States, the FDA regulates stem cells. They balance the interests of the first two groups and put an end to the third. As with most medical innovations, there are areas of grey. 

 The National Institute of Health (NIH) takes a very active role in stem cell therapy, making the public aware of both the benefits and drawbacks. They offer advice on how to choose a clinic that has the qualifications expected by their peers. 

In February of 2018, both the FDA and the NIH joined the American Academy of Orthopaedic Surgeons at Stanford University to:

 (1) establish a clear, collective impact plan for improving the clinical evaluation, use, and optimization of biologics in orthopaedics and 

(2) develop a guidance document on clinically meaningful endpoints and outcome metrics to accelerate the evaluation of biologics for common orthopaedic conditions.

The outcome was twofold. First, the participants created a framework for developing trials. Second, they co-wrote the recommendation for both physicians and institutions offering these therapies. They want signatories to commit to maintaining high-quality registries used for quality assessment. By January 21, 2020, full reviews were being assessed and published.

A Word from the Mayo Clinic

 The Mayo Clinic runs many critical studies testing stem cell therapy and, in 2016, completed the first-ever test of cell therapy to treat arthritis. When the American Journal of Sports Medicine published the study, there were over 600 stem cell clinics in the US treating 100,000 patients.

Dr. Shane Shapiro, the lead author of the study, was interviewed when the findings were confirmed.

Our Position

At the New York Institute of Hormone Replacement, we see patients who respond to hormone replacement very well. So well, that they do not pace themselves and over-extend their bodies. They can tear ligaments or damage cartilage. Common reasons include running too fast or far or trying to make up for lost treadmill time. 

Stem cell therapy can be the best solution for them. Healing takes time because the stem cells regenerate soft tissue. While the patients heal, they learn to adjust to their newfound energy.

We limit our work to the appendicular skeleton – the shoulder, arm, hand, pelvis, leg, and foot. We support stem cell therapy on the appendicular skeleton because the treatments are highly stable. The research is deep and proven.

In the axial skeleton – the spinal cord – we refer patients to highly regulated clinical trials.  Our colleagues at Cedar Sinai and other research centers participate in approved Investigational New Drug Applications (IND) issued by the FDA.