Regenokine is an anti-inflammatory treatment for joint pain and inflammation. The procedure injects beneficial proteins collected from your blood into your affected joints.
The treatment was developed by Dr. Peter Wehling, a German spinal surgeon, and has been approved for use in Germany. Many prominent athletes, including Alex Rodriguez and Kobe Bryant, have traveled to Germany for Regenokine treatment and reported that it relieves pain.
Although Regenokine isn’t yet approved by the Food and Drug Administration (FDA), it’s used off-label at three sites in the United States that are licensed by Wehling.
Regenokine is similar to platelet-rich plasma (PRP) therapy, which uses your own blood products to help regenerate tissue in an injured area.
In this article, we’ll review what the Regenokine procedure is like, how it differs from PRP, and how effective it is for pain relief.
What is Regenokine?
In his early development of Regenokine, Wehling successfully treated Arabian horses that had experienced joint injuries. After continuing his research with humans, Wehling’s formulation was approved for human use in 2003 by the German equivalent of the FDA.
The procedure concentrates the proteins in your blood that fight inflammation and promote regeneration. The processed serum is then injected back into the affected joint. The serum has no red blood cells or white blood cells that can cause irritation.
The serum may also be called autologous conditioned serum, or ACS.
What does the Regenokine procedure involve?
Before the procedure, a Regenokine specialist will work with your primary healthcare provider to determine whether you’re a good candidate for this treatment. They’ll make their determination by examining your standard blood work and imaging scans of your injury.
If you get the go-ahead, here’s what to expect during the procedure:
Your blood will be drawn
A doctor will draw about 2 ounces of blood from your arm. This takes only several minutes.
Your blood will be processed
The temperature of your blood sample will be slightly elevated for up to 28 hours in a sterile environment. It will then be placed in a centrifuge to:
- separate the blood products
- concentrate the anti-inflammatory proteins
- create a cell-free serum
Depending on your situation, other proteins may be added to the serum.
According to Dr. Jana Wehling, an orthopedist and trauma specialist who works with her father at the Regenokine clinic in Dusseldorf, Germany, “Additions to the serum include recombinant proteins like IL-1 Ra, local anesthetics, or low-dose cortisone.”
The treated sample is then frozen and put into syringes for injection.
Your blood will be reinjected into the affected joint
The reinjection process takes a few minutes. Peter Wehling has recently introduced a technique for a single injection (the Regenokine® One Shot), instead of one injection each day for 4 or 5 days.
The doctor may use ultrasound as an imaging aid to position the injection site accurately.
If serum is left over, it can be frozen for use in the future.
No recovery downtime needed
There’s no downtime following the procedure. You’ll be able to resume your activities immediately after the reinjection.
The time it takes for you to feel relief from pain and swelling varies by individual.
How does Regenokine work?
According to Peter Wehling, the treated Regenokine serum has up to 10,000 times the normal concentration of anti-inflammatory protein. This protein, known as interleukin-1 receptor antagonist (IL-1 Ra), blocks its inflammation-causing counterpart, interleukin 1.
Dr. Christopher Evans, director of the Rehabilitation Medicine Research Center at the Mayo Clinic, explained it this way: “The ‘bad interleukin,’ interleukin 1, combines with a specific receptor on the surface of the cell that responds to it. It docks there. And after that, all sorts of bad things happen.”
“The good interleukin,” continued Evans, “is the interleukin-1 receptor antagonist material. This blocks the (cell’s) receptor. … The cell doesn’t see the interleukin-1, because it’s blocked, and therefore, bad things don’t happen.”
It’s thought that IL-1 Ra may also counteract the substances that lead to cartilage and tissue breakdown and osteoarthritis.
Is Regenokine effective?
Studies of Regenokine show that it’s effective in most people, but not all.
The Wehling clinic’s material states that they consider the Regenokine treatment successful when a patient’s pain or functioning improves by 50 percent. They use standard questionnaires for people who have the treatment to rate its effect.
The clinic estimates that about 75 percent of people with mid-stage knee osteoarthritis and pain will have success with the treatment.
U.S. doctors licensed to use Regenokine have a similar success rate. It’s been shown to postpone the need for a joint replacement, or to avoid the need for a joint replacement in some people.
Why doesn’t Regenokine work for everyone?
We asked Evans, who worked with Peter Wehling early in his research, why Regenokine works for most people but not for everyone. Here’s what he said:
“Osteoarthritis isn’t one homogeneous disease. It comes in many variations and it’s probable that there are various subtypes, some of which will respond, and some not. Dr. Wehling developed an algorithm for this using various components of the patient’s DNA. People with certain DNA sequences were predicted to be better responders.”
Dr. Thomas Buchheit, MD, CIPS, director of Regenerative Pain Therapies at Duke University — one of the three sites in the United States that are licensed to use the serum developed by Wehling — also noted, “We see the best outcomes with folks who have mild to moderate arthritis, not bone on bone.”
What the studies say
Small studies have looked at the Regenokine treatment, also referred to as autologous conditioned serum (ACS), for joint pain. Some compare it to other treatments. Other studies look at specific joints.
Here are a few recent studies:
- A 2020 study of 123 people with osteoarthritis compared ACS to PRP treatment. The study found that the ACS treatment was effective and “biochemically superior to PRP.” The people who received ACS had significantly better pain reduction and function improvement than those who had PRP.
2018 studyof 28 people with knee or hip osteoarthritis found that the ACS treatment produced “a rapid decline in pain” and an increase in range of motion.
2020 reviewof regenerative pain medicine compares Regenokine with other regenerative treatments. It reports that ACS “reduces pain and joint damage in arthritis.”
2017 studyof 47 people with meniscus lesions treated found that ACS produced significant structural improvements after 6 months. As a result, surgery was avoided in 83 percent of the cases.
2015 studyof 118 knees treated with ACS found a rapid improvement in pain sustained for the 2 years of the study. Only one person received a knee replacement during the study.
How many people have been treated?
According to Jana Wehling, “The Regenokine program has been in clinical use for approximately 10 years and an estimated 20,000 patients have been treated worldwide.”
The first generation of Regenokine, Orthokine, was used to treat more than 100,000 patients, she said.
What about regeneration of cartilage?
As Evans put it, cartilage regeneration is the holy grail for people who work with osteoarthritis. Can Regenokine regenerate cartilage? It’s a question under research by Peter Wehling and his lab.
When asked about cartilage regeneration, Jana Wehling replied: “Indeed, we have clear scientific proof for muscle and tendon regeneration under ACS. There are signs of cartilage protection and also regeneration in animal experiments as well as in human clinical application,” she said.
“But cartilage regeneration is very difficult to prove in clinical studies.”
What’s the difference between Regenokine and PRP therapy?
PRP therapy draws your own blood, processes it to increase the concentration of platelets, and then reinjects it into an affected area.
Your blood is run through a centrifuge to concentrate platelets, but it’s not filtered. It’s thought that the higher concentration of platelets helps speed healing of the area by releasing necessary growth factors.
PRP isn’t yet approved by the FDA, and usually isn’t covered by insurance. The cost of a PRP treatment varies from $500 to $2,000 per injection. However, it’s used fairly often in treating musculoskeletal conditions.
Orthopedic surgeon Dr. Laura Timmerman put it this way: PRP is “an OK thing to try first… but Regenokine has a better chance of getting the patient better.”
Regenokine uses a standardized processing regimen
Like Regenokine, PRP is a biologic therapy. But Regenokine has a standardized processing regimen, with no discrepancies in the formulation, says Jana Wehling.
In contrast, PRP is prepared individually with
Regenokine removes blood cells and other potentially inflammatory ingredients
Unlike Regenokine, PRP is not cell-free. It contains white blood cells and other parts of the blood that may cause inflammation and pain when injected, according to Dr. Thomas Buchheit, at Duke University’s Center for Translational Pain Medicine.
In contrast, Regenokine is purified.
Is Regenokine safe?
The safety of Regenokine isn’t in question, according to many experts. As Mayo Clinic’s Evans put it: “The first thing to know is that it’s safe. That can be said categorically.”
There are no reports of adverse effects in the studies of Regenokine.
FDA approval is needed to have Regenokine used in the United States because the reinjection of your treated blood sample is considered to be a drug.
FDA approval requires a wide range of studies and millions of dollars to support the research.
How much does Regenokine cost?
Regenokine treatments are costly, about $1,000 to $3,000 per injection, according to Jana Wehling.
A full series on average has four to five injections. The price also varies according to the body region treated and its complexity. For example, Jana Wehling said, in the spine “we inject into many joints and surrounding nerves during one session.”
Not covered by insurance in the United States
In the United States, Regenokine is used off-label by licensed affiliates of Peter Wehling. The pricing follows that of Wehling’s practice in Dusseldorf, Germany, and the treatment isn’t covered by insurance.
Orthopedic surgeon Timmerman says that she charges $10,000 for the injection series for the first joint, but half that for the second or subsequent joints. She also notes that one blood draw may give you several vials of serum that can be frozen for later use.
Each treatment plan is “custom-tailored” to the individual’s needs, according to Jana Wehling. Other factors may affect the cost, such as “the type and severity of disease, individual pain situation, clinical complaints, and comorbidities (pre-existing illnesses).”
She stressed that their goal is to bring the price down.
How long does Regenokine treatment last?
Whether Regenokine needs to be repeated varies by individual and by the severity of your condition. Peter Wehling estimates that relief for knee and hip arthritis can last between 1 to 5 years.
People who respond well to the treatment usually repeat it every 2 to 4 years, Peter Wehling says.
Where can I find a qualified provider?
The office of Peter Wehling in Dusseldorf, Germany, licenses and regularly inspects the labs of doctors who administer Regenokine therapy. They want to ensure that the treatment is performed correctly and in a standardized fashion.
Here’s the contact information for the clinic in Dusseldorf and three U.S. sites that are licensed to use the treatment:
Dr. Wehling & Partner
Peter Wehling, MD, PhD
Duke Regenerative Pain Therapies Program
Raleigh, North Carolina
Thomas Buchheit, MD
Santa Monica, California
Chris Renna, DO
Laura Timmerman, MD
Walnut Creek, California
Phone: 925- 952-4080
Regenokine is a treatment for joint pain and inflammation. The procedure processes your own blood to concentrate beneficial proteins and then injects the treated blood into the affected area.
Regenokine is a stronger formulation than platelet-rich plasma (PRP) therapy, and it performs better and for a much longer period than PRP.
Regenokine is approved for use in Germany, where it was developed by Dr. Peter Wehling, but it doesn’t yet have FDA approval in the United States. It’s used off-label at three sites in the United States that are licensed by Wehling.
More studies are needed to confirm the efficacy of Regenokine and obtain FDA approval.
The treatment is safe and effective, according to clinical studies and medical experts. The drawback is that Regenokine is an expensive treatment that has to be paid out of pocket in the United States.