Stem Cell Knee Clinical Trials

Stem cell therapy for knee arthritis or knee osteoarthritis is gaining popularity among patients. Over the last few years, there has been an increasing number of patients with knee pain that are performing google searches to explore the option of stem cell therapy for their knee arthritis. 

And for good reason.  Although knee replacement surgery is successful for many, stem cell therapy offers a new alternative to knee pain and knee replacement surgeries.

Benefits of Stem Cell Therapy for Knee Pain

1. Compared to knee replacement surgery, stem cell therapy is a much simpler procedure.  Only requiring mild sedation, patients are fully conscious during the procedure and feel less pain.
2. If stem cell therapy fails, patients can always get a traditional knee replacement. However, if knee replacement surgery fails, you are unable to have stem cell therapy.
3. Knee replacement lasts about 10-15 years. After this time period, many patients require a second surgery which is usually more complex. However, stem cell therapy can be easily repeated as it is noninvasive.
4. Knee replacement requires extensive physical therapy for months. Where as physical therapy after stem cell therapy is minimal in comparison.

For more reasons on this matter, check out our ‘Why stem cell therapy is better than surgery’ post.

Stem Cell Therapy Clinical Trials for Knee Arthritis

Although, stem cell therapy for knee arthritis or osteoarthritis is a relatively new procedure. Many patients do wonder if there are any clinical trials. Also, they want to know if this technique is successful and if it is safe. Here, we will analyze the clinical trials to answer the above questions.

One of the best trials is from an orthopedic surgeon in France, Dr. Phillipe Hernigou who is considered the father of orthopedic stem cell therapy. In this trial, he selected 30 patients who had significant pain in both knees from severe knee damage. In each patient, he injected one knee with bone marrow stem cells and performed Knee replacement surgery on the other knee. He then compared the results. These are the findings.

1. Pain relief was similar with stem cell therapy and Knee replacement
2. However 70% were satisfied with stem cell therapy and only 30% were satisfied with Knee replacement. This is a very significant finding.
3. More importantly, 20% of Knee replacements required a second surgery
4. Knee replacements had complications and stem cell therapy had none.

When the stem cell therapy patients were followed for 12 years, pain relief was still maintained. This is the most salient feature of the study which showed that the results from stem cell therapy are long lasting.

Dr.Hernigou published another landmark trial in which he compared the results of injecting bone marrow stem cells in the knee bone vs injecting stem cells in the knee joint. 60 patients suffering with severe pain in both knees from serious osteoarthritis were enrolled. In each patient, one knee had stem cells injected into the bones and the other knee was injected with stem cells into the knee joint. These were his findings.

1. At the 2 year follow up, patients with bone injection had superior pain relief. 
2. More importantly bone injections prevented the progression of arthritis. 
3. After 15 years, Knee replacement could be avoided in 80% of patients. This is an important finding.

It is worth noting that patients with bone injection maintained their pain relief even after 15 years.

However, injecting the bones in the knee is more complex than injecting the joint. It does take special expertise and training from the physician and since it is also more painful, epidural anesthesia is required. Very few clinics in the globe offer this procedure and StemCures is one of them.

Dr.Centeno published 3 trials assessing the efficacy and safety of bone marrow stem cells to treat knee arthritis.

In one study, he evaluated the response of high dose cells and low dose cells in patients suffering from knee pain from arthritis. 224 patients had low dose cells and 185 patients had high dose cells. Cell number less than 400 million was considered low dose and more than 400 million was deemed high dose. Although both doses reported good pain relief, patients who had high doses reported better outcomes.

At StemCures, we adopt a special technique for bone marrow aspiration which consistently produces high doses. It is extremely rare that we inject less than 400 million cells. This is one of the main reasons for our success rate. 

In another study, he injected bone marrow stem cells in the knee in 22 patients who were suffering from knee pain. He compared the pain relief obtained in these patients to the pain relief in 26 patients who did not get the stem cells but were placed in an exercise program. These patients were followed for 2 years. He reported that after 2 years, patients who received stem cells were not only more functional but also had superior pain relief. 

In one study, Dr.Centeno injected bone marrow stem cells in the arthritic knee joints in 616 patients. In another 224 patients in addition to the stem cells he also injected fat graft to assess if combining fat graft with stem cells would provide better relief. He reported that both groups showed good results and the addition of fat graft did not reveal additional benefits. 

Our anecdotal experience about adding fat graft to bone marrow stem cells also revealed that addition of fat graft did not improve outcomes and sole injection of stem cells provided good pain relief.

Dr.Oliver injected bone marrow stem cells into 254 patients who were suffering from moderate to severe osteoarthritis of the knee. They followed the patients for 2 yrs. Improvement in pain, functioning and stiffness of the knee were noted in these patients.

In another study, Dr.Oliver injected bone marrow stem cells into 70 patients who were suffering from moderate to severe osteoarthritis of the knee. They followed the patients for 6 months. Improvement in pain, functioning and quality of life were noted in these patients. Interestingly, there was an increase in IRAP, a protein which is extremely anti-inflammatory in the stem cell product.

In a different study, 15 patients with moderate to severe knee osteoarthritis were injected with bone marrow stem cells. This study was unusual because these patients received 4 separate injections about a 2-5 weeks gap between injections. They have found that patients were getting better pain relief with each subsequent injection.

It is interesting that each procedure in this trial was done with only 20 cc of bone marrow. This may explain why patients needed 4 injections to see good pain relief. At StemCures we use 60 cc of bone marrow and hence are seeing good results with only one time procedure. 

In one of the most intriguing trial, 30 patients with pain in both knees were enrolled. In each patient, bone marrow stem cells were injected into the joint in one knee and saline[salt water] was injected in the other knee joint. Fascinatingly, after 6 months, significant pain relief was seen in both knees. 

In a trial by Mendoza, 26 patients with knee arthritis were injected with bone marrow stem cells and in comparison 26 patients were treated with tylenol. Patients who received stem cells reported significant relief and functional improvement at 6 months compared to the tylenol group. 

Regarding safety of bone marrow stem cells, one of the best evidence was published by Dr.Centeno. He reported 2372 patients from his registry who underwent 3012 stem cell therapy procedures for various orthopedic conditions. No major complications from this therapy were identified in these patients. 

To summarize, analysing the data from all the clinical trials where bone marrow stem cells were injected into the knees of patients suffering from painful arthritis, the following conclusions can be made.

1. Stem cell therapy is effective in relieving pain
2. Stem cell therapy improves function
3. Stem cell therapy is safe with no complications reported

At StemCures, we have been doing stem cell therapy for knees since 2017. We are seeing good results for the following reasons.

1. We have a special bone marrow extraction technique which allows us to place the maximum possible stem cells in the knee. We routinely aspirate at least 2-3 times the number of cells compared to what is reported in the literature.
2. Knee pain from arthritis usually is from many structures like the bone, cartilage, meniscus etc. After evaluating the MRI, We routinely inject all the structures capable of causing pain.
3. Like any procedure, results depend directly on the expertise and the training of the physician performing the procedure. Dr.Atluri has published many articles on stem cells therapy and is also a Co-editor of the largest stem cell textbook on musculoskeletal pain. 

Because of the above, our patients see good results. Click here for our patient video testimonials and here for our google reviews. 

This is a video of Linda who was suffering from knee pain resulting from severe arthritis. She is doing very well after stem cell therapy from StemCures.