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300 Participants NeededMy employer runs this trial

CARTISTEM for Osteoarthritis

(CARTISTEM23-01 Trial)

Recruiting at 15 trial locations
AO
Overseen ByAdrian Orr, VP Clinical Development
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Medipost, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

To establish the efficacy and safety of CARTISTEM®, a combination product composed of allogeneic human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) formulated with a cross-linked sodium hyaluronate (HA) hydrogel, CARTISTEM® compared to the surgical comparator of debridement in Subjects with knee cartilage lesions and osteoarthritis.

This trial is intended to provide evidence of the superiority of CARTISTEM® to reduce knee pain and improve knee function compared to debridement for Subjects with knee cartilage lesions and osteoarthritis at 2-years post-treatment.

Additionally, this trial is intended to intended to explore whether CARTISTEM® may have disease-modifying effects on osteoarthritis progression through the use of semi-quantitative MRI assessment.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 75 years old.
I have been diagnosed with knee osteoarthritis according to ACR guidelines.
My knee arthritis is moderate to severe, as confirmed by an X-ray.
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What Are the Treatments Tested in This Trial?

Interventions

  • CARTISTEM®

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: CARTISTEM + DebridementExperimental Treatment1 Intervention
Group II: DebridementActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medipost, Inc.

Lead Sponsor

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