Does Stem Cell Therapy Work for Knee Pain ?

If you are in Cincinnati or any other city and suffering from knee pain due to arthritis and are exploring Stem Cell options, you probably had these questions.

Are there any clinical trials for stem cells to treat knee arthritis? Does stem cell therapy work for knee pain? Can stem cells be an alternative to total knee replacement? Do stem cells regenerate knee cartilage?

I looked into the medical literature to find answers. I was looking specifically for FDA allowed treatments.

Why did I look for only FDA allowed treatments? Because legitimate stem cell clinics offer FDA compliant treatments.

So that restricted me to only bone marrow stem cells. I eliminated cultured or expanded bone marrow stem cells. What are Cultured stem cells? These are stem cells are taken out of your bone and cultured in a lab to increase the numbers. They are then re-injected into the areas of pain. They are not approved by the FDA. Since FDA does not also allow Allogenic bone marrow stem cells [stem cells from other humans], I did not include their studies. I also ignored Fat, Amniotic, Umbilical Cord stem cells as they seem not to be allowed per FDA regulations. I also did not include any study which involved the surgical placement of stem cells.

To summarize, only studies which met the following criteria were analyzed in this blog.

Patient’s own bone marrow stem cells

After centrifugation and concentration, Stem cells were immediately injected back into the knee

Stem cells were placed into the knee percutaneously [using needles and not surgery]

Pain coming from osteoarthritis of the knee

There were a lot of clinical trials for stem cells to treat knee arthritis. However, only 7 studies specifically used bone marrow stem cells to treat knee pain. I will be talking about these studies in this blog.

This study published by Dr.Hernigou in January of 2018 says that stem cell therapy is better than knee replacements.

Here, 30 patients with bilateral knee osteonecrosis were randomly assigned to receive either the traditional total knee replacement in one knee or their own bone marrow stem cells in the other knee. Stem cells were injected into the 2 knee bones. These patients were followed for an average of 12 years. In terms of pain relief, both groups had similar decrease in pain scores. However, in the stem cell group, there was about 4% increase in the knee cartilage and a 3cm cubic area decrease in the bone arthritis. Most importantly, 21 of the 30 patients were satisfied with stem cell therapy compared to only 9 of the 30 patients who had the knee surgery. 6 of the 30 knees which were operated required a second surgery whereas only 3 in the stem cell group needed a second surgery. 30% of patients in the surgery group had blood transfusion versus none in the stem cell group. 15% of patients in the surgery group had clots develop in their legs. None of the patients in the stem cell group had clots. This is important to note because these clots in the leg, if undetected can travel to the lungs and cause death.No major side effects were reported in the stem cell group.

To summarize this clinical trial, stem cells provided similar relief to total knee replacement but had more patient satisfaction, fewer complications, and less revision surgery. Regeneration of knee cartilage and decrease in the bone arthritis was also seen in the stem cell patients.

This study is important because it is the only study to date which compared the efficacy of bone marrow stem cells with a total knee replacement. It is also the only study which tracked outcomes for about 12 years.

Does stem cell therapy work in knee pain from Arthritis? According to this elegant study by Hernigou, IT DOES WORK.

Can stem cells be an alternative to total knee replacement? According to this study, IT SEEMS LIKE A BETTER ALTERNATIVE.

Do stem cells regenerate knee cartilage? Based on MRI findings in this study, YES.

A large study by Dr.Centeno published in September of 2015 says that stem cell therapy works and the dose of the Stem Cells matters.

In this study, 373 patients that received stem cell injections intraarticularly, either with ultrasound or flouroscopy, to treat 424 osteoarthritic knee joints. Most joints were diagnosed with early stage knee osteoarthritis. TNC [Total Nucleated Cell] count is a surrogate marker for the number of stem cells. He divided patients into two groups. One group had a lower (≤4 × 108) cell count and the second group had a higher (>4 × 108) cell count. There were 185 patients in the high cell count group and 224 in the lower group. The stem cells were mixed with platelet lysate and injected into the joint. If some patients exhibited meniscal injury, the meniscus was also injected. Patients in both the higher and lower cell counts groups showed improvement in pain and function. However patients in higher cell count group received 50% more relief than the lower group. This underscores the importance of proper aspiration techniqueto maximize the stem cell count. No major side effects were reported.

This study is important because of the large number of patients and they followed for more than a year.

Does stem cell therapy work in knee pain from Arthritis? According to this large study by Centeno, IT DOES WORK AND IS DOSE DEPENDENT.,

Can stem cells be an alternative to total knee replacement? According to this study, IT SEEMS LIKE A POSSIBLE ALTERNATIVE.

Do stem cells regenerate knee cartilage? This was not addressed in the study.

Another big study, also from Dr.Centeno, published in September 2014 shows that bone marrow stem cells work. Addition of fat graft did not improve results.

In this study 840 procedures were performed in 742 patients with knee arthritis. Bone marrow concentrate injected intra-articularly, either with ultrasound or fluoroscopy in the knee. 224 were done with adipose graft and 616 were done without. The stem cells were mixed with platelet lysate and injected into the joint. If some patients had a meniscal injury, the meniscus was also injected. Although functional improvement was mixed, pain relief was observed in both groups even after one year. Addition of adipose graft did not improve results. No major side effects were reported.

This study is important as it had the largest number of patients so far and they followed for more than a year.

Does stem cell therapy work in knee pain from Arthritis? According to this large study by Centeno, IT DOES WORK AND ADDITION OF FAT GRAFT DID NOT IMPROVE RESULTS.

Can stem cells be an alternative to total knee replacement? According to this study, IT SEEMS LIKE A POSSIBLE ALTERNATIVE.

Do stem cells regenerate knee cartilage? This was not addressed in the study.

A study from Dr.Oliver published in 2015 showed that bone marrow stem cells along with fat graft work.

In this study, 70 patients with moderate to severe knee osteoarthritis received intraarticular bone marrow stem cells along with fat graft. Ultrasound guidance was used to inject the joint capsule. Even after 180 days, patients reported pain relief and an increase in activity. No major side effects were reported.

Does stem cell therapy work in knee pain from Arthritis? According to this study, IT DOES WORK ALONG WITH THE ADDITION OF FAT GRAFT.

Can stem cells be an alternative to total knee replacement? According to this study, IT SEEMS LIKE A POSSIBLE ALTERNATIVE.

Do stem cells regenerate knee cartilage? This was not addressed in the study.

The study reported by Dr.Shaw in June of 2018 reveals that small doses of stem cells injected at 4 different times helps with knee arthritis.

In this study, 15 patients [20 knees] with moderate to severe knee osteoarthritis had bone marrow stem cells injected 4 times over a period of about 9 weeks. The procedure was performed under ultrasound guidance into the knee joint capsule. Traditionally 60 cc of bone marrow is aspirated and centrifuged to generate 3-5 cc of bone marrow concentrate which is full of stem cells. Here only 20 cc of bone marrow was aspirated. So, small doses were injected 4 times instead of one large dose one time. With respect to subjective overall improvement, the largest improvement (43.8%) occurred after the first treatment. The next 3 treatments were associated with a 7.95% mean improvement resulting in a mean 67% total overall improvement after 4 treatments. In addition, 7 knees reported 80% or more overall improvement. Functionality also improved with each treatment. No major side effects were reported.

Does stem cell therapy work in knee pain from Arthritis? MULTIPLE SMALL DOSE BONE MARROW INJECTIONS DO WORK.

Can stem cells be an alternative to total knee replacement? According to this study, IT SEEMS LIKE A POSSIBLE ALTERNATIVE.

Do stem cells regenerate knee cartilage? This was not addressed in the study.

The study from Dr.Shapiro which was published in 2016 shows that “saltwater” is as good as stem cells. Both gave good pain relief.

In this study, 25 patients with bilateral knee pain from osteoarthritis [mild to moderate] received bone marrow stem cells into one knee and saline [salt water] in the other knee. Both the procedures were done under ultrasound. Interestingly both groups reported significant pain relief along with an increase in function up to at least 6 months. Interestingly, even the authors struggled to explain why saline provided similar relief as stem cells. No major side effects were reported.

Does stem cell therapy work in knee pain from Arthritis? BONE MARROW STEM INJECTIONS DO WORK AND INTERESTINGLY GIVE SIMILAR RELIEF AS SALINE. EVEN THE AUTHORS WERE UNABLE TO EXPLAIN WHY SALINE PROVIDED PAIN RELIEF.

Can stem cells be an alternative to total knee replacement? According to this study, IT SEEMS LIKE A POSSIBLE ALTERNATIVE.

Do stem cells regenerate knee cartilage? This was not addressed in the study.

A small study by Dr.Rodriguez showed that stem cells help with patients with low-grade arthritis.

In this study, 10 patients with early osteoarthritic knees joints were injected with stem cells. Even after more than a year, most patients reported pain relief along with improvement in function. No complications were noted.

Does stem cell therapy work in knee pain from Arthritis? BONE MARROW STEM INJECTIONS DO WORK.

Can stem cells be an alternative to total knee replacement? According to this study, IT SEEMS LIKE A POSSIBLE ALTERNATIVE.

Do stem cells regenerate knee cartilage? This was not addressed in the study.

Another study by Garay- Mendoza et al revealed that bone marrow stem cells helps in patients with moderate arthritis.

Here, 61 patients in the control group were treated with 150 cc of bone marrow aspirate which was concentrated down to 10 cc of bone marrow concentrate. This concentrate was injected intra-articularly [blind] in the knee with patients suffering from moderate arthritis. After 6 months, the mean pain score fell from 4.64 to 0.92. Patients also reported improvement in function. There was also a control group which was treated with Tylenol and patients in this group did not show much improvement.

Does stem cell therapy work in knee pain from Arthritis? BONE MARROW STEM INJECTIONS DO WORK.

Can stem cells be an alternative to total knee replacement? According to this study, IT SEEMS LIKE A POSSIBLE ALTERNATIVE.

Do stem cells regenerate knee cartilage? This was not addressed in the study.

George S.Themistocleous et al published a study which showed that Bone marrow stem cells helped patients with severe arthritis.

In this study, 121 patients with moderate to severe arthritis were treated with bone marrow concentrate injection into the knee joint blindly. After 11 months, there was a reduction of pain and improvement in function.

Does stem cell therapy work in knee pain from Arthritis? BONE MARROW STEM INJECTIONS DO WORK.

Can stem cells be an alternative to total knee replacement? According to this study, IT SEEMS LIKE A POSSIBLE ALTERNATIVE.

Do stem cells regenerate knee cartilage? This was not addressed in the study.

Summarized the findings from the above studies are found in the Table below

IA: Intraarticular Injection, SC: Subchondral Injection, NE: Not Evaluated,

Conclusion

7 studies with a total of 1265 patients, evaluated the efficacy of stem cells for arthritis pain in the knee. All the studies reported pain relief with improvement in function. Most importantly there were no side effects or complications. Based on the currently available clinical studies, bone marrow stem cells seem like a viable option to treat knee arthritis and maybe a good option to avoid surgery.

If you want the best result from your stem cell procedure, please make sure that the following 3 conditions are met:

Your doctor is well qualified. If the doctor performing the procedure is not well trained or if the procedure is done by a Nurse Practitioner or a Physician Assistant, not only will you not get any pain relief but also you are at high risk for complications. Make sure your doctor is using your own bone marrow stem cells. They are the best stem cells as they have a proven long-term history of efficacy and safety. Make sure that the doctor is injecting all the right areas of pain by using an x-ray machine or an ultrasound machine or both.

End of the day it is your hard earned money. Most importantly, it’s your health.

In our clinic, in Cincinnati, we are seeing good results as reflected in the above studies. Watch the video to see Diane’s pain relief from knee arthritis using her own bone marrow stem cells.

