CARTISTEM® – Phase III Clinical Trial

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CARTISTEM® – Phase III Clinical Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis

This is a Phase 3 clinical trial of the investigational therapy Cartistem for the treatment of Knee Osteoarthritis. Cartistem uses allogeneic-umbilical cord blood-derived mesenchymal stem cells to reduce knee pain and improve dysfunction caused by osteoarthritis. This procedure may offer
a regenerative approach for patients who have not found relief through conservative treatments. The study involves a minimum of 9 visits over 24 months with visit compensation.

Source Healthcare is proud to announce its involvement in a pivotal Phase III clinical trial for Medipost’s investigational therapy, CARTISTEM®. This innovative treatment aims to provide lasting relief for patients suffering from pain caused by knee osteoarthritis, a condition that affects millions and limits daily functioning.

Overview of the Medipost Cartistem® Clinical Trial

The Medipost Phase III clinical trial is a groundbreaking study that aims to evaluate the safety and effectiveness of an innovative regenerative therapy for chronic low back pain caused by degenerative disc disease. CARTISTEM® is made up of allogeneic human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) formulated with a cross-linked sodium hyaluronate (HA) hydrogel. All subjects will undergo a knee debridement procedure, and the
group randomized to treatment will also receive a dose of CARTISTEM® to achieve a minimal clinically important difference in knee pain and function scores in comparison to the sham procedure.

Participants in the trial will undergo a structured program, including an initial screening phase, a single procedure, and follow-up visits over 24 months. The study is a step in offering treatment for patients who have not found relief through conventional therapies, providing hope for long-term pain management and improved quality of life.

Study Design and Visit Requirements

The Medipost

Phase III clinical trial is a structured program that aims to assess the efficacy and safety of CARTISTEM®. Participants will engage in the study over 24 months, with a minimum of 9 visits to the research site. These visits are divided into three distinct phases: screening, treatment, and follow-up. Here’s what you can expect during each phase.

Screening Phase

Before beginning the trial, you will undergo a thorough screening to
determine your eligibility. This includes a medical history review, diagnostic tests, imaging (MRI and XRay) and discussions with our clinical team about your health and pain history. The goal is to confirm that you meet all the criteria for participation, ensuring the trial is suitable for your condition and will deliver meaningful results.

Treatment Phase

Once enrolled, you will undergo a knee debridement as well as an injection
of CARTISTEM® (the investigational treatment) or a placebo (sham) as part of the study’s control group. The treatment aims to reduce knee pain and improve knee function compared to debridement for subjects with knee cartilage lesions and osteoarthritis at 2-years post-treatment.

Follow-Up Phase

After the procedure, you will participate in regular follow-up visits over 24 months. These visits allow our team to monitor your progress, assess your response to the treatment, and ensure your overall health. You’ll undergo physical exams, pain assessments, and functional evaluations. This phase is critical for understanding the long-term benefits of the intervention.

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Potential Benefits of Participation:

  • Access to a state-of-the-art regenerative therapy that could alleviate knee pain.
  • All treatments, assessments, and diagnostics are covered at no cost to you or your insurance.
  • Participants will receive compensation for their time and travel associated with the study.

Cost and Compensation for Participation

Participating in the Medipost clinical trial comes at no cost to you. All treatments, diagnostic procedures, and assessments required for the study are fully covered by the trial sponsor. Additionally, you will receive compensation for your time and travel to each of the follow up visits over the 24-month study period. This ensures you can focus on your health and participation without financial burden.

You May Be Eligible to Participate in the Study If:

  • You are 18-75 years of age
  • You have not found relief conservative knee osteoarthritis treatment for at least 3 months
  • You have been diagnosed with knee osteoarthritis
  • You are not pregnant or planning to become pregnant during the 24-month study period
  • You have received an intraarticular injection to the index knee within 3 months
  • You have received prior knee replacement surgery or nerve ablation at the index knee

Previous Research:

CARTISTEM® is not approved for use in the United States; however, it is approved in Korea and has been in use since 2012. See here for published studies on the use of Cartistem in Korea:

How to Enroll in the CARTISTEM® – Phase III Clinical Trial

If you are interested in participating or would like more information about the ReGelTec Clinical Trial, we invite you to contact our research team.

Phone: Call (310) 574-2777

Email: research@sourcehealthcare.com

(310) 574-2777

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