We take a look at what the research actually tells us about Stem Cells treating Arthritis.
If you want to know more about how Clinics use Stem Cells to treat arthritis, check out our article on Stem Cell Therapy for Arthritis. Or if you’re looking to see the best clinics for Stem Cell Therapy, reach out to us here!
Current Trials
There’s been a recent boost in Trials looking at testing Stem cells on Arthritis, with around 40 Trials around the world right now, with over 12 of them being done in East Asia and circa 13 across the US. We look at four of the most interesting trials happening right now (links to the actual pages are included, if you click on the heading of each one!)
NCT06463847 – China
Location: Wuhan Union Hospital, China
Participants: Adults aged 50-70 with moderate knee osteoarthritis
Phase: I
Details: This trial is testing human umbilical cord mesenchymal stem cells (UC-MSCs) to treat knee osteoarthritis (KOA). Participants are split into three groups to receive different doses: 5 million, 10 million, or 20 million cells.
What’s particularly interesting about this study is the high cell count being tested. A lot of earlier trials either didn’t specify how many cells they used or stuck with lower doses. This one goes big, with 20 million cells in the highest group. The researchers want to see if giving more cells actually makes a difference and what the safest dose is for patients.
They’ll measure things like pain reduction and joint function using scales like WOMAC and VAS, aiming to figure out if this approach could set a new standard for treating KOA. If it works, it might be a game-changer for people dealing with this condition.
NCT04339504 – South Korea
Location: Seoul National University Hospital, South Korea
Participants: Adults 19+ who completed the initial Phase I trial of SMUP-IA-01
Phase: I (Follow-Up)
Details: This follow-up study is monitoring participants who previously took part in a Phase I trial of SMUP-IA-01, a mesenchymal stem cell therapy derived from human umbilical cord blood, for knee osteoarthritis (KOA). The study spans 60 months, making it one of the longest follow-up trials for KOA treatment, and aims to evaluate the long-term safety and effectiveness of this therapy.
Subjects are divided into three groups based on dosage:
- Low dose: 4 million cells
- Mid dose: 10 million cells
- High dose: 20 million cells
This study stands out because it uses higher cell doses than most previous trials, which often either stuck to lower counts or didn’t specify dosages at all. With a five-year follow-up period, it also offers a rare chance to explore the long-term safety and effectiveness of stem cell therapy—a key area where research has been lacking. By combining these higher doses with extended monitoring, the trial could shed light on how dosage impacts safety and sustained benefits for KOA patients.
Location: Various sites across California, including Santa Monica and Newport Beach.
Participants: 140 individuals aged 18 and older with knee osteoarthritis.
Phase: 2b/3a
Details:
This study is a double-blind, randomized, placebo-controlled trial, which means participants are randomly assigned to either the treatment or placebo group, and neither the participants nor the researchers know who is in which group. This ensures unbiased results. One group receives JointStem, a treatment using autologous adipose tissue-derived mesenchymal stem cells (AdMSC), while the other group receives a placebo.
The trial includes a rigorous 48-week follow-up with assessments at key intervals to measure outcomes such as WOMAC scores, VAS pain levels, and knee structural changes through imaging.
As a U.S.-based trial, it does not specify the cell count being used, likely due to stringent FDA regulations. These regulations emphasize safety and often result in lower cell doses or less transparency in dose reporting to meet strict guidelines. This highlights a key difference between U.S. studies and those in other countries, where regulatory frameworks often allow for higher doses to be administered and openly documented.
Location: Hope Biosciences Research Foundation, Sugar Land, Texas
Participants: 66 children aged 2–16 with oligoarticular or polyarticular juvenile idiopathic arthritis (JIA)
Phase: 2 (Recently approved by the FDA for Phase 2 trials, c.December 19th 2024)
Details:
This study, which has just received FDA approval to move to Phase 2, aims to tackle JIA—a condition that disrupts the lives of children with ongoing joint pain and inflammation. The trial is designed as a double-blind crossover, so all participants will receive both the stem cell treatment and a placebo at different times, allowing researchers to compare the effects directly.
The treatment involves three infusions of adipose-derived mesenchymal stem cells (HB-adMSCs) over an 8-week period, with dosages based on body weight (50, 100, or 200 million cells). After this, there’s a 12-week washout period before switching treatments. Researchers will track changes in symptoms, inflammation markers (like CRP and ESR), and overall quality of life over the course of 72 weeks.
Being approved for Phase 2 is a big deal—it means the treatment has passed early safety checks and can now be tested on a larger group to see how effective it really is. For families of kids with JIA, this represents a new level of hope. Instead of just managing symptoms, this study is exploring whether stem cell therapy can genuinely improve joint health and reduce inflammation long-term.
Studies Completed since 2020
There haven’t been many recent studies who have posted results since 2020, we’ve collated a couple for you here!
Raza et al. (2023)
Location: Ayub Teaching Hospital, Bahawal Victoria Hospital, and Dar As Sihha Medical Center, Pakistan
Participants: 50 people, including 35 with osteoarthritis and 15 with bone defects, who received stem cell therapy between January and September 2023.
Method: Doctors gave injections of stem cells (taken from the patient’s fat or bone marrow) directly into joints or affected areas. The study tracked pain levels and movement ability for six months, using simple tools to measure pain (VAS) and function (WOMAC). It also recorded any side effects.
Results:
Pain Relief: Pain scores dropped from an average of 7.4 (out of 10) before treatment to 5.2 after six months.
Better Movement: Scores for stiffness and physical ability improved, going from 56.8 to 41.2 over six months.
Side Effects: Side Effects: 28% of patients had some side effects, such as pain, redness, or swelling at the injection site, and temporary stiffness or soreness. More serious issues were reported by 8% of patients, including infections at the injection site and adverse immune reactions.
Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES)
Location: This study took place across four U.S. sites: Gulf Breeze, Florida; Atlanta, Georgia; Durham, North Carolina; and Sioux Falls, South Dakota.
Participants: A total of 475 individuals aged 40–70 years with unilateral knee osteoarthritis (OA) were enrolled. Participants were divided into four treatment groups.
Methods:
– Bone Marrow-Derived MSCs (BMAC): MSCs were obtained via bone marrow aspiration and concentrated using FDA-approved methods. While the exact cell count wasn’t disclosed, BMAC typically yields hundreds of thousands to a few million MSCs.
– Adipose-Derived MSCs (SVF): These cells were collected through liposuction, then processed enzymatically to produce stromal vascular fraction (SVF). Specific cell counts weren’t mentioned but are usually in the millions.
– Umbilical Cord Tissue MSCs (UCT-MSCs): Participants received injections containing 20 million cryopreserved MSCs.
– Corticosteroid Injection (Control): The control group received standard corticosteroid injections.
Participants were randomized in a 3:1 ratio to receive either the MSC therapy assigned to their group or the corticosteroid injection. All treatments were administered with ultrasound guidance, and participants didn’t know which therapy they received (single-blind study).
Findings
– Pain Reduction: All MSC groups reported less pain compared to the corticosteroid group, with the UCT-MSC group showing the most improvement.
– Functionality: MSC-treated participants experienced better mobility, reduced stiffness, and improved quality of life, as reflected in KOOS and PROMIS-29 scores.
– Cartilage Regrowth: MRI scans showed evidence of cartilage regeneration in MSC-treated groups, particularly those receiving UCT-MSCs.
– Safety: There were no serious side effects directly linked to the MSC treatments, indicating they were safe to use.
This study highlights the exciting potential of MSC therapy, particularly UCT-MSCs with a 20-million-cell dose, as a promising option for treating knee OA. While the results are encouraging, further research is needed to confirm the long-term effects and refine optimal dosing strategies.
Real-World Evidence Case Series
A real-world evidence (RWE) case series is a type of study that looks at how treatments work in everyday medical practice. Unlike clinical trials, which happen in tightly controlled settings, these studies show how treatments perform for real patients with different needs and conditions. They help doctors and researchers understand if a treatment is safe, effective, and practical in normal healthcare settings. This kind of research is valuable because it reflects what happens in the real world, not just in labs or specialized clinics.
Real-World Evidence of Mesenchymal Stem Cell Therapy in Knee Osteoarthritis: A Two-Year Case Series
Objective: This study looked at how safe and effective adipose-derived mesenchymal stem cell (ADMSC) therapy is for treating knee osteoarthritis (OA) over two years in real-world conditions.
Location: Australia
Methods: A total of 329 people with knee OA received ADMSC therapy and were followed for 24 months. Their OA was classified into different levels of severity (Grades I-IV) based on x-rays and MRIs. To collect the stem cells, doctors used a simple procedure to take fat tissue from the patients. The stem cells were then prepared in a lab and injected into the patients’ knees at the start of the study and again six months later.
Results:
Safety:
– There were no serious side effects reported during the two years of follow-up.
– Some patients experienced mild to moderate pain, swelling, or stiffness after the injections, but these issues went away with basic care like ice and over-the-counter pain relief.
Effectiveness:
– On average, patients reported a 54% decrease in pain after two years.
– People’s ability to move and use their knees improved significantly, as shown by better scores on standard tests (KOOS and WOMAC).
– Those with severe OA (bone-on-bone) saw a 44.8% drop in pain, while people with moderate OA improved the most, with a 70.2% reduction in pain.
Impact on Surgery:
– Many patients avoided or delayed needing total knee replacement surgery, especially those with active jobs requiring a lot of physical movement.
Discussion: This study backs up earlier clinical trials, showing that ADMSC therapy is safe and works well for reducing pain and improving knee function. It could also help reduce healthcare costs by delaying the need for surgery like total knee replacement. The results were consistent across patients of all ages and body types, which means it might work for a wide range of people.
Conclusion: ADMSC therapy is a promising, non-surgical option for treating mild to severe knee OA. It provides long-lasting pain relief and helps patients move more easily. This study highlights its potential as a practical solution for people with knee OA.
Why This Matters: Real-world evidence studies like this one show how treatments work in everyday healthcare, not just in controlled clinical trials. These findings strengthen the case for using ADMSC therapy as a reliable option to delay surgeries and improve the quality of life for people living with OA.
Limitations: While the study provides valuable insights, it has some limitations:
– No Control Group: The lack of a placebo or comparative control group makes it hard to confirm whether the improvements are entirely due to ADMSC therapy.
– Potential Bias:Researchers’ affiliations with Magellan Stem Cells and Melbourne Stem Cell Centre may introduce bias, even with oversight measures in place
– Limited Long-Term Data:The study covers only two years, leaving questions about how long the benefits last beyond this period.
Reviews
Review 1: on 35 Clinical Trials
This review, published in the International Journal of Molecular Sciences by researchers in Brazil, dives into the potential of mesenchymal stem cell (MSC) therapies for treating osteoarthritis (OA). By analyzing 35 clinical trials, it explores how MSCs could help address the challenges of cartilage repair and symptom relief in OA
Key Takeaways
- Are MSC Therapies Safe?
– Most patients experienced only mild side effects, like joint pain or swelling, which went away quickly.
– There weren’t any severe safety concerns, making MSC treatments generally safe to use. - Do MSCs Work for Osteoarthritis (OA)?
– MSC treatments showed promising results in reducing pain, improving how well joints work, and easing OA symptoms.
– Many patients reported feeling better, but MSCs currently can’t fully repair the damaged cartilage in joints. - Where Do MSCs Come From?
– MSCs can be taken from sources like bone marrow, fat tissue, umbilical cords, or placentas.
– Most studies used cells from the patient’s own body (autologous MSCs), but donor cells (allogeneic MSCs) also worked well. - What’s Holding Back Cartilage Repair?
– MSCs don’t last long enough in the joint, and the inflammation caused by OA makes it harder for them to repair cartilage.
– Current treatment methods need improvements to create stronger, longer-lasting cartilage similar to what’s in a healthy joint. - What’s Missing in Clinical Trials?
– Many studies didn’t have control groups or enough participants, making their results less reliable.
– Only a few trials (29%) included large groups of people or tracked long-term results (over 5 years). - What’s Next for MSC Treatments?
– Researchers are exploring ways to make MSCs work better, like genetically modifying them, protecting them with gels, or combining them with other therapies.
– New tech, like 3D printing cartilage, could eventually transform how we treat OA.
Review Summary
MSC therapies are safe and show promise for reducing OA symptoms like pain and stiffness, but they’re not yet a full solution for rebuilding damaged cartilage. More research is needed to figure out the best way to use MSCs and to confirm their long-term benefits with larger, better-designed studies.
Review 2: Literature, Studies & Clinical Trials
This review, published in the International Journal of Molecular Sciences by researchers from West China Hospital, takes a close look at how mesenchymal stem cell (MSC) therapies could help with osteoarthritis (OA). It focuses on the potential for MSCs to repair cartilage and reduce symptoms, drawing insights from recent studies and clinical trials.
Key Takeaways:
Are MSC Therapies Safe?
The good news is, most patients in these trials only reported mild side effects, like some joint pain or swelling, which cleared up quickly. There weren’t any serious safety concerns, which suggests that MSC treatments are generally safe.
Do MSCs Work for Osteoarthritis?
The results so far look promising! MSC treatments helped reduce pain, improve joint function, and ease other OA symptoms. However, while many patients felt better, these therapies still can’t fully rebuild the damaged cartilage in joints—at least, not yet.
Where Do MSCs Come From?
MSCs can be sourced from bone marrow, fat tissue, umbilical cords, or even placentas. Most trials used MSCs taken from the patient’s own body (autologous), but donor cells (allogeneic MSCs) also seemed to work well.
Why Can’t MSCs Fix Cartilage Completely?
There are a couple of hurdles. MSCs don’t stick around in the joint for very long, and the inflammation caused by OA makes it harder for them to repair cartilage. Researchers are working on ways to improve this so the cells can do a better job. One point as you read below, could be the amount of cells offered per treatment.
What’s Missing in These Trials?
A lot of studies didn’t have enough participants, didn’t include control groups, or didn’t track patients over the long term. Fewer than one in three trials followed patients for more than five years, so there’s still a lot we don’t know about how well MSCs work in the long run.
Are MSCs Prepared the Same Way Across Studies?
Not quite. While researchers followed general guidelines, there’s still room for improvement when it comes to making sure MSCs are consistent and high quality across all trials.
What About the Number of Cells Used?
Here’s an interesting point: the trials in this review used much lower cell counts, usually between 1,000 and 50,000 cells per treatment. That’s a big difference compared to the 500,000 to 1 million or more cells that many stem cell clinics use. It’s possible that higher cell counts could lead to better results, but no one has tested these larger doses in well-designed clinical trials yet.
This review looked at how mesenchymal stem cell (MSC) therapy affects knee osteoarthritis (KOA), analyzing 16 trials with 875 patients. Researchers compared MSCs from different sources to see how well they reduce pain, restore joint function, and help with injury recovery.
Key Takeaways
Does MSC Therapy Reduce Pain?
– Pain relief started showing up as early as three months after treatment.
– MSCs from adipose tissue (fat) and umbilical cords seemed to work best for easing pain.
– Interestingly, using your own fat-derived MSCs (autologous) was more effective for pain than donor cells (allogeneic).
– However, when it came to bone marrow-derived MSCs, autologous cells didn’t perform any better than donor cells.
What About Joint Function?
– If you’re looking for better knee movement and function, MSCs from your own fat tissue seem to be the best option. They consistently outperformed other sources in measures like WOMAC and the Lysholm Knee Scale.
Does It Heal Joint Damage?
Here’s the catch: even though MSCs help with pain and function, they didn’t show a clear advantage in actually repairing joint damage when assessed through MRI scores (WORMS).
Does Adding HA or PRP Help?
Combining MSCs with other treatments like hyaluronic acid (HA) or platelet-rich plasma (PRP) didn’t make a noticeable difference in outcomes.
Is It Safe?
Yes! Across the studies, there were no major safety concerns, making MSC therapy a safe option to consider.
Review Summary
MSC therapy can ease pain and improve joint function for people with KOA, and it’s generally safe. If you’re thinking about this treatment, fat-derived MSCs from your own body might offer the best results. But keep in mind, MSCs haven’t yet proven they can actually repair joint damage. There’s still work to be done to figure out the best sources, doses, and techniques to get the most out of these therapies.
Conclusion
Stem cells are showing a lot of promise in the fight against arthritis. Studies using MSCs from sources like fat tissue and umbilical cords have revealed some pretty exciting results: less pain, better movement, and even hints of cartilage regrowth in some cases. That’s huge because traditional treatments only focus on managing symptoms, not fixing the damage.
But it’s not all smooth sailing. There are still some things researchers are working out like how many cells are needed. It looks like a higher cell count is better – which agrees with the reasoning behind why Clinics in certain countries offer cell counts in the millions. And, we still are working on more long term data to see how long treatments are effective, if there’s other potential side effects down the road etc.
If you’re thinking about getting this treatment for your arthritis, good news is safety wise, it’s pretty solid. There’s good evidence with a high cell count, both your own Stem cells and those taken from Umbilical cord help with pain & symptom relief, with the latter being more effective.
But it might not always fully re-grow your cartilage, that still varies from person to person.
