We have collated a complete list of every Stem Cell Therapy trial for Osteoarthritis currently recruiting in the US as of December 2025. So you find the trial that fits your specific condition.
Alt Treatment does not recruit for or promote any specific clinical trials. If you’re thinking about participating, final decisions regarding participation should be made in consultation with qualified medical professionals.
If you need guidance on how to apply or check your eligibility, reach out to our team, we’re more than happy to assist.
Phase II/III JointStem Osteoarthritis Stem Cell Trial Currently Recruiting in California, United States
You can read about the study on their clinical trials page.
Who’s Running It
- This trial is being run by Nature Cell Co. Ltd., a biotechnology company.
- It’s taking place in multiple locations across the United States and South Korea.
Participants
- Around 140 adults with knee osteoarthritis are expected to join the study.
- All participants will be randomly assigned to receive either the real stem cell treatment (JointStem) or a placebo (a harmless fake injection) to compare results.
- The study will last for 48 weeks (about 1 year) for each person.
What They’re Testing
- This trial is testing whether Mesenchymal stem cells from a patient’s own body fat can help reduce pain and improve movement in people with knee osteoarthritis.
Here’s how it works:
- A small amount of fat is taken from the patient’s body using a minor procedure (called lipoaspiration).
- Mesenchymal stem cells from that fat are collected and prepared in a lab.
- The stem cells are then injected directly into the knee joint.
- The hope is that these cells will help repair damaged tissue, reduce pain, and improve how well the joint works.
What They’re Measuring
Main Goals (Primary Outcomes):
- Ability to function in daily life, using a score called WOMAC function score.
- Level of knee pain, using a simple 0–100 pain scale (VAS).
- Both of these will be measured before and after treatment, especially at the 48-week mark.
Other Things They’re Tracking (Secondary Outcomes):
- Pain and function levels at earlier time points (weeks 12, 24, 36).
- Overall knee health using X-rays and joint scans.
- Use of rescue medications (like acetaminophen).
- Changes in quality of life using standard health questionnaires.
Timeline
- Start Date: May 26, 2021
- Estimated End Date: December 31, 2026
- Key Results Expected By: December 30, 2026
Requirements to Join
Please review the criteria below to see if you qualify.
Who Can Join
You Cannot Join If
We know it’s confusing & difficult to understand if your eligible for different trials. Talk to our team who can help you understand if you’re a fit.
Knee Osteoarthritis Clinical Stem Cell Trial Currently recruiting in Chicago, United States
You can read about the study on their clinical trials page.
Who’s Running It
- This study is run by Rush University Medical Center in Chicago, Illinois.
- It is being led by Dr. Brian Cole.
- The study started in 2017 and is still actively recruiting patients.
Participants
- Around 100 patients are expected to take part.
- All patients are getting surgery for a torn meniscus (called a meniscectomy).
- After the surgery, patients are randomly split into two groups:
- One group receives a stem cell injection (made from their own bone marrow).
- The other group gets a placebo injection.
- The study is double-blinded, meaning neither the patient nor the doctor knows who got what.
What They’re Testing
- This trial is testing whether injecting a person’s own bone marrow stem cells, called BMAC, into the knee after meniscus surgery can help:
- Slow or prevent arthritis from getting worse.
- Improve knee pain, function and mobility over time.
Here’s how it works:
- During the same surgery where the torn meniscus is removed, the doctor also collects bone marrow from the upper part of the shin bone.
- The bone marrow is run through a machine that spins it quickly to separate and concentrate the useful parts, including stem cells and growth factors.
- This is called Bone Marrow Aspirate Concentrate.
- The concentrated solution is then injected directly into the knee joint at the end of the surgery.
- The other group goes through the same process, but instead receives a saline injection without any cells.
What They’re Measuring
Main Goal (Primary Outcome):
- Improvement in knee function at 1 year, measured using the IKDC score (a standard knee health questionnaire).
Other Outcomes (Secondary Measures):
- Changes in pain, knee function, and stiffness using:
- WOMAC (a questionnaire for arthritis).
- VAS (a 0–10 pain scale).
- KOOS (Knee Injury and Osteoarthritis Outcome Score).
- SF-12 (general health survey).
- MRI and X-ray images to track joint changes.
- Synovial fluid testing to look for changes in inflammation and arthritis markers.
These will be tracked over multiple time points, including:
- 7–10 days, 6 weeks, 3 months, 6 months, 1 year, and 2 years after the surgery.
Timeline
- Started: December 2017
- Estimated End Date: December 31, 2026
- Primary Results Expected: November 2026
Requirements to Join
Please review the criteria below to see if you qualify.
Who Can Join
You Cannot Join If
We know it’s confusing & difficult to understand how to apply for trial like these. Talk to our team who can help walk you through what you need to do.
Phase I/II StroMel Knee Osteoarthritis Clinical Stem Cell Trial recruiting in Maryland, USA
You can read about the study on their clinical trials page.
Who’s Running It
- This study is being run by Akan Biosciences, a U.S.-based biotech company.
- It is taking place in Gaithersburg, Maryland.
- The study has been approved by the FDA for testing StroMel in humans and is focused on people with moderate to severe knee osteoarthritis.
Participants
- Only 20 adults will take part in this early-phase safety study.
- All participants will receive StroMel, a type of experimental stem cell injection made from their own body fat.
- There is no placebo group in this trial. Everyone gets the treatment.
What They’re Testing
- This trial is checking whether StroMel is safe to use in humans with osteoarthritis of the knee.
Here’s what’s being done:
- A small amount of fat is collected from the patient’s body.
- Using technology called AUIC, or ultrasonic isolation, stem cells and other helpful components are separated without using harsh enzymes.
- The final product is injected directly into the knee joint.
- The idea is that these cells may help reduce pain, improve joint health and possibly slow down arthritis.
- But in this early phase, the main focus is on safety, not effectiveness.
What They’re Measuring
Primary Goals (Safety Outcomes)
- The study will track if any serious side effects occur within 12 months of treatment.
Side effects they’re watching for include:
- Severe joint infections.
- Allergic reactions or immune responses.
- Worsening knee pain.
- Any signs of unusual growths or tumors at the injection site.
Secondary Goals (Efficacy Signals)
- Whether patients reduce their use of NSAIDs (like ibuprofen) over 52 weeks.
- Improvements in pain and function based on:
- WOMAC score (a standard arthritis scale).
- VAS pain score (a 0–100 pain scale).
Timeline
- Expected Start Date: October 1, 2025
- Estimated End Date: August 31, 2027
- This is a Phase 1/2 study, meaning it focuses mostly on safety, but also looks at early signs of whether it might work.
Requirements to Join
Please review the criteria below to see if you qualify.
You may be eligible if you:
You cannot join if you:
We know it’s confusing & difficult to understand if your eligible for different trials. Talk to our team who can help you understand if you’re a fit.
Phase I CFL001 Clinical Stem Cell Trial for SIJ Syndrome now recruiting: Florida, United States
You can read about the study on their clinical trials page.
Who’s Running It
- This study is being run by the University of Florida, in collaboration with Cord for Life, Inc.
- It is sponsored by the university and takes place at:
- University of Florida Pain Clinic (Gainesville, Florida)
- The trial has been approved by the FDA and includes full safety monitoring.
Participants
- This is a small early-phase trial (9 people total) designed to test safety.
- To join, participants must:
- Be 18 to 90 years old.
- Have sacroiliac joint (SIJ) syndrome, with moderate to severe pain in the lower back.
- Still be able to walk and go about daily life.
- Have tried physical therapy, medications, and other standard treatments without success.
- Either have one painful SI joint (unilateral) or both (bilateral), only one will be treated.
What They’re Testing
- The treatment being tested is called CFL001, a type of umbilical cord blood product designed to help reduce inflammation and pain in the SI joint.
- The product is manufactured under strict quality standards (cGMP) and contains live stem cells derived from cord blood.
In this study:
- Doctors inject the stem cells directly into the SI joint using ultrasound guidance.
- Participants are grouped by dose levels:
- Low dose: 30 million total nucleated cells (TNC)
- Medium dose: 60 million TNC
- High dose: 90 million TNC
- Dosing goes step-by-step: only if a lower dose is safe, will the next group get a higher one.
- This is a non-randomized, open-label study, everyone knows what they’re receiving.
How the Stem Cells Are Used
- Stem cells are injected directly into the joint (intra-articular injection).
- Ultrasound is used to precisely guide the injection.
- Participants do not receive surgery, this is a same-day injection procedure.
- Each group (3 people per group) gets a different dose level.
- The study is watching carefully for any dose-related effects on safety or improvement.
Safety Checks & Monitoring
- The study’s primary focus is safety.
- Doctors are monitoring all side effects and serious medical events.
- Vital signs like blood pressure and heart rate.
- Any reason a participant needs to stop early.
- Whether higher doses increase risks.
- Participants are followed up at 7, 30, 90, and 180 days after treatment for check-ins.
What They’re Measuring
Primary Goal (Main Focus):
- Whether the treatment is safe and well-tolerated.
- Doctors are using standard safety scoring (CTCAE v5) and checking for any serious issues.
Secondary Goals:
- Whether stem cells help reduce pain (measured by VAS pain scale).
- Whether they improve quality of life (measured by PROMIS 29 questionnaire).
- Whether physical activity improves (tracked with wearable actigraphy devices).
Timeline
- Study Started: May 2024
- Primary Results Expected: March 2027
- Study End Date: March 2028
Requirements (Who Can Join)
Please review the criteria below to see if you qualify.
Who Can Join
You Cannot Join If
We know it’s confusing & difficult to understand how to apply for trial like these. Talk to our team who can help walk you through what you need to do.
Risks of joining a Osteoarthritis Stem Cell Trial
- Unknown Long-Term Effects (Especially With Umbilical or Donor Cells)
- Allogeneic stem cells (like from umbilical cord or placenta) may look promising now, but:
- We don’t know the full long-term immune risks, including graft-vs-host effects or chronic inflammation
- There is still limited data on whether injected MSCs stick around or die off
- Some preclinical data hints at risks like ectopic tissue growth, but human trials haven’t been long enough to rule these out
- We don’t know the full long-term immune risks, including graft-vs-host effects or chronic inflammation
- Allogeneic stem cells (like from umbilical cord or placenta) may look promising now, but:
- Joint Pain, Swelling, and Post-Injection Flare-Ups
- Intra-articular injections often trigger short-term issues:
- Swelling, heat, stiffness
- Sharp pain or pressure at the injection site
- Post-injection flare (inflammation spike within 24–72 hours)
- Swelling, heat, stiffness
- Intra-articular injections often trigger short-term issues:
- No Guaranteed Benefit, Even in Late-Stage Trials
- Many OA stem cell trials fail to meet their primary endpoints, especially when looking at:
- Structural changes (like cartilage thickness)
- Long-term pain reduction
- Structural changes (like cartilage thickness)
- Many OA stem cell trials fail to meet their primary endpoints, especially when looking at:
- You May Have to Stop Your Current Pain Medications
- Trials often require stopping:
- NSAIDs (ibuprofen, naproxen)
- Tramadol
- Supplements like glucosamine or turmeric
- NSAIDs (ibuprofen, naproxen)
- If your OA is currently manageable with meds, this may cause a temporary spike in pain
- Some trials disqualify you if you’re on corticosteroids or have had a recent injection
- Trials often require stopping:
No, for most Trials it won’t cost you.
There are certain “self-funded” trials, which are mainly treatments being offered by Stem Cell Therapy clinics.
Yes, Stem Cell injections can work for many people with knee pain. Stem Cell injections reduce inflammation, relieve pain, and improve joint function by promoting the body’s natural healing process. However, results can vary depending on factors like the severity of your condition, the type of stem cells used, and the clinic’s expertise. But it’s not always a guaranteed fix
Because chemotherapy and recent cancer can weaken the immune system or increase risk of complications, some trials exclude these patients to protect their safety and avoid confounding the results.
Kellgren and Lawrence refers to a grading system used to classify the severity of osteoarthritis (OA) based on X-ray images. It ranges from:
Grade 0 – No signs of OA
Grade 1 – Doubtful/narrowing of joint space, possible bone spurs
Grade 2 – Definite bone spurs, possible joint space narrowing
Grade 3 – Moderate joint space narrowing, multiple bone spurs, some deformity
Grade 4 – Severe joint space narrowing, large bone spurs, obvious deformity
VAS score stands for Visual Analog Scale, a simple tool used to measure how much pain a person is feeling.
It’s usually a 0 to 100 scale, where 0 means no pain and 100 means the worst pain imaginable. Participants mark their pain level on a line, which helps researchers track changes over time.
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