Osteoarthritis Clinical Stem Cell trials recruiting now in the US

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

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

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.

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