Regenerative Medicine: 6 Tips For Avoiding A Bad Clinic

Overview

Growing demand for regenerative treatments like platelet rich plasma (PRP) and stem cell injections has lead to an explosion of clinics offering regenerative therapies in Colorado. Despite the wide variety of clinics to choose from, a 2018 paper highlighted alarming variances in treatment strategy between stem cell clinics in the United States. Experts are concerned that many clinics offering regenerative therapies may be profiteering from the high-dollar, out-of-pocket price of injections, while lacking consistent quality control and best practices.

In This Article

We will discuss six tips to help you avoid bad clinics and find reputable clinics that will give you the greatest chance of a successful outcome. While doing your research, you'll need to figure out the following:

1. Who's doing the procedure?
2. Is the clinic grading candidacy?
3. What type of cells is the clinic using?
4. How is the clinic processing cells?
5. Is the procedure performed with image guidance?
6. Is the clinic tracking and reporting outcomes?

1. Who is performing the procedure?

Currently, there is minimal regulation regarding who can and cannot perform stem cell injections nor is there a standard training program that physicians must attend prior to offering stem cell treatment. For the above reasons, there are a wide variety of doctors of different skill levels offering these treatments, such as orthopedic surgeons, interventional radiologists, physiatrists, plastic surgeons, anesthesiologists, and family practitioners. As with most medical procedures, the injection of stem cells into a joint or ligament requires careful understanding of human anatomy and medical imaging. If you are considering stem cell treatment, it is crucial to ensure the doctor you choose has the knowledge and skillset to deliver safe and successful results. Questions to assess your doctor's skill Here are a few questions you can ask to get a better sense of your doctor's skill level with injection procedures:

• How were you trained to perform stem cell injections?
• How many procedures have you performed on this body part?
• Have you received formal training on how to perform image guided procedures?

2. Is the clinic grading candidacy for their procedures?

When evaluating which patients are likely to benefit from regenerative therapy, it is important to ensure any clinic is stratifying patients into categories based on the likelihood of procedural success. With almost any medical procedure, there are patients who are good candidates, fair candidates, and poor candidates for the procedure; regenerative treatments are no different. Questions to assess if a clinic is grading candidacy Asking the following questions to your regenerative medicine doctor to determine if they are grading your candidacy for a procedure.

• Why do you think this procedure is likely to succeed for me?
• What factors did you consider when offering this treatment to me?
• What factors make someone a poor candidate for regenerative medicine?

3. What type of cells is the clinic using?

Depending on the stem cell clinic, there are a wide variety of materials that could be injected into your body. For instance, bone marrow derived stem cells have the most data supporting their ability to regrow orthopedic tissue when compared to other stem cell types derived from amniotic, umbilical, or adipose (fat) tissues. It is also important to note that the safest type of cell to use is an autologous stem cell, i.e., a stem cell from your own body. There is an increased risk for a negative immunologic reaction when using cells from someone else. Questions to assess what cells a clinic is using Ask the following questions to understand what cell types your doctor will be using:

• Are you using autologous stem cells from my body?
• Are the stem cells you're using derived from bone marrow, fat, or some other tissue?

4. How is the clinic processing cells?

Cells must be processed and concentrated prior to injecting them back into your body. Differing processes can factor into procedural success. For example, recent literature suggests that higher concentrations of platelets in platelet rich plasma (one of the major components of a stem cell injection) can lead to increased stem cell activation, especially in older patients. Certain commercial stem cell "kits" are unable to concentrate platelet rich plasma enough to initiate meaningful stem cell activation. Questions to assess how a clinic is processing cells Ask the following questions to get a better sense for how platelet rich plasma (PRP) or bone marrow-derived stem cells are being processed:

• Are you able to precisely control the concentration of PRP or stem cells for my injection?
• What type of equipment do you use to concentrate my cells?

MEDICAL INSIGHT

Platelet rich plasma (PRP) falls into three categories:

1. Red PRP: As the name implies, this form of PRP is red in color, contains lower levels of platelets, and is rich in white blood cells. White blood cells cause inflammation when injected; therefore, red PRP is thought to be less effective in orthopedic procedures.
2. Low Concentration Amber PRP: This form of PRP is amber in color, contains a moderate number of platelets, but very few red and white blood cells. This form of PRP causes less tissue inflammation and swelling when injected into tissue and is therefore considered to be the ideal PRP type for tendon and ligament injuries.
3. High Concentration Amber PRP: This form of PRP is almost identical to low concentration amber PRP but contains a larger number of platelets. This type of PRP is thought to be ideal for the treatment of joint arthritis.

5. Is the procedure performed with image guidance?

Image-guided procedures are procedures where the doctor uses real-time imaging to ensure the proper placement of an injection into injured tissue. If the injection is inappropriately targeted, there is a lower chance of success. Examples of real-time imaging include ultrasound (the machine used to evaluate fetal progression during pregnancy) and fluoroscopy (which displays a continuous x-ray image). Questions to assess if the clinic is using image guidance Ask the following questions to make sure the clinic you choose is using image guidance:

• Will my procedure be performed with image guidance?
• What type of image guidance will be used?

6. Is the clinic tracking and reporting outcomes?

While regenerative therapies are rapidly advancing, the field is still relatively young. As such, clinics have a responsibility to measure and track functional improvement after a procedure to inform future patients about the benefits, risks, and expected outcomes of regenerative therapies. Outcomes tracking, or systematically following up with patients at predefined intervals after their procedure, allows clinics to improve their techniques over time. Questions to assess if a clinic is tracking outcomes Ask the following question about outcomes tracking to your regenerative medicine doctor:

• Does your clinic maintain a patient registry to document patient progress after an injection?
• Are patient outcomes from your procedures available online or upon request?