Knee Osteoarthritis Clinical Trial in Colorado
Now Enrolling Eligible Participants
Living with Chronic Knee Osteoarthritis Pain?
Consider the CARTISTEM Phase 3 Clinical Trial
If knee pain is making it harder to walk, stay active, or enjoy daily life, you may be looking for options beyond physical therapy, medications, injections, or activity changes.
Orthopedic Centers of Colorado is now enrolling eligible adults in a Phase 3 knee osteoarthritis clinical trial in Colorado. This study is evaluating CARTISTEM®, an investigational regenerative therapy for adults with knee osteoarthritis and painful cartilage damage.
The study is led at OCC by Justin Newman, MD, a fellowship-trained orthopedic sports medicine surgeon who specializes in cartilage restoration, joint preservation, and minimally invasive knee surgery.
If you’ve been diagnosed with knee osteoarthritis and still have knee pain after trying conservative treatment, you may qualify.
Schedule a Screening Consultation
Call 720-974-5233 or email kneepain@occ-ortho.com to speak with the OCC clinical research team.
About the CARTISTEM® Clinical Trial
This Phase 3 clinical trial is studying whether CARTISTEM®, an investigational therapy made from donated umbilical cord blood mesenchymal stem cells, may help improve knee pain and function in adults with knee osteoarthritis and symptomatic cartilage defects.
In simpler terms, researchers are studying whether this investigational regenerative therapy may help people with knee arthritis-related pain and cartilage damage move more comfortably and function better.
The study is sponsored by MEDIPOST Inc.
CARTISTEM® is investigational and has not been approved by the U.S. Food and Drug Administration. Its safety and effectiveness have not yet been established.
Why Consider This Study
Knee osteoarthritis can make everyday activities harder, including walking, climbing stairs, exercising, working, or spending time with family.
Many people try conservative treatments first, such as:
- Physical therapy
- Anti-inflammatory medications
- Knee injections
- Bracing
- Activity modification
- Rest and home exercise
For some people, these treatments may not provide enough relief. At the same time, they may not be ready for knee replacement surgery.
This clinical trial is designed to evaluate whether CARTISTEM® may offer another option for carefully selected patients in the future.
What Participants May Receive
Eligible participants in this knee osteoarthritis clinical trial may receive:
- Study-related physician visits at no cost
- Study-related imaging, procedures, testing, and follow-up evaluations at no cost
- Compensation for eligible time and travel related to study visits
- Close monitoring by Dr. Justin Newman and the OCC clinical research team
- The opportunity to participate in research that may help advance future treatment options for knee osteoarthritis
Participation in a clinical trial is voluntary, and the research team will explain the study requirements before you decide whether to enroll.
Who May Be Eligible?
You may qualify for this study if you:
- Are between 18 and 75 years old
- Have been diagnosed with knee osteoarthritis
- Have painful cartilage damage in the knee
- Continue to have knee pain after at least three months of conservative treatment
- Meet the study’s medical eligibility requirements
You may not qualify if you:
- Are pregnant or planning to become pregnant during the 24-month study period
- Have had an injection in the affected knee within the past three months
- Have previously had knee replacement surgery or nerve ablation in the affected knee
- Have certain medical conditions that do not meet the study requirements
Final eligibility is determined during the screening process by the clinical research team.
What to Expect
This study lasts approximately 24 months and includes a minimum of nine study visits. Eligible participants may receive compensation for time and travel.
Before joining the study, you’ll complete a screening visit to help determine whether the trial is a good fit for you.
This may include:
- A review of your medical history
- A physical exam
- MRI and X-rays
- A discussion about your knee symptoms
- A review of treatments you’ve already tried
- An evaluation of study eligibility
Eligible participants will undergo a knee debridement procedure.
After that, participants will be randomly assigned to receive either the investigational CARTISTEM® therapy or the comparison treatment required by the study protocol.
The purpose of the study is to compare outcomes and evaluate whether CARTISTEM® may improve knee pain and function.
After treatment, participants will return for scheduled follow-up visits over 24 months.
At these visits, the research team will monitor your recovery and knee function through:
- Physical exams
- Imaging
- Knee function assessments
- Patient questionnaires about symptoms, mobility, and daily activities
- These visits help researchers better understand the long-term safety and effectiveness of the investigational therapy.
Meet Dr. Justin Newman
Dr. Justin Newman is a fellowship-trained orthopedic sports medicine surgeon at Orthopedic Centers of Colorado. He specializes in knee, shoulder, and hip injuries, with expertise in cartilage restoration and joint preservation.
His areas of expertise include:
-
Cartilage restoration
-
Joint preservation
-
Ligament reconstruction
-
Minimally invasive arthroscopic surgery
As Principal Investigator for this knee osteoarthritis clinical trial in Colorado, Dr. Newman oversees the study at OCC and works closely with the clinical research team throughout the process.
Frequently Asked Questions
Is CARTISTEM® FDA approved?
No. CARTISTEM® is investigational and has not been approved by the U.S. Food and Drug Administration. This clinical trial is evaluating its safety and effectiveness.
Is there any cost to participate?
No. The study sponsor covers study-related physician visits, imaging, procedures, testing, and follow-up evaluations required by the research protocol.
Will I be paid for participating?
Eligible participants may receive compensation for time and travel related to study visits.
How long does the study last?
Participants are involved in the study for approximately 24 months, including a minimum of nine study visits.
Will I definitely receive CARTISTEM®?
Not necessarily. Participants are randomly assigned to receive either the investigational CARTISTEM® therapy or the comparison treatment required by the study protocol.
How do I know if I qualify?
The first step is to schedule a screening consultation with the OCC clinical research team. They will review your medical history, symptoms, imaging, and other study requirements to determine whether you may be eligible.
Ready to Learn More?
If you’re living with ongoing knee osteoarthritis pain and conservative treatments haven’t provided enough relief, you may qualify for this clinical trial.
The OCC clinical research team can answer your questions, explain what participation involves, and help determine whether the study may be right for you.
Contact Our Clinical Research Team
Schedule Your Screening Consultation Today!
Trial Clinic Locations
Aurora Southlands
