Stem Cell Therapy for Osteoarthritis

KD
Overseen ByKathryn Dziedzic, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new stem cell treatment called XytriX to determine its safety and effectiveness for people with knee osteoarthritis. The goal is to assess whether different doses of XytriX can alleviate knee pain and improve movement. Participants may qualify if they have experienced knee osteoarthritis symptoms for at least three months, are already using other treatments like medication or physical therapy, and suffer from significant knee pain. As a Phase 1 and Phase 2 trial, this research aims to understand how XytriX works in people and measure its effectiveness in an initial, smaller group, offering participants the chance to be among the first to benefit from this innovative treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants may be receiving conservative therapy like oral anti-inflammatory medication, so you might be able to continue those. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that stem cell therapy, such as XytriX, is generally safe for treating knee osteoarthritis. A review of many studies found no major safety concerns with these treatments. Another study found that cell-based treatments improved pain and function without causing safety issues. Additionally, stem cells from umbilical cords, like those in XytriX, have a strong safety record, supported by over 20 years of published evidence. Earlier patients responded well to these treatments, with few serious side effects reported.12345

Why do researchers think this study treatment might be promising for osteoarthritis?

Unlike the standard treatments for osteoarthritis, which typically involve pain relievers or anti-inflammatory medications, XytriX is a stem cell therapy that directly targets joint repair. Researchers are excited about XytriX because it uses stem cells to potentially regenerate damaged cartilage, offering a more long-term solution rather than just symptom relief. XytriX is administered as an intra-articular injection, and the trial is exploring different doses—10 million, 30 million, and 50 million cells—to find the most effective regenerative impact. This innovative approach could change the way we manage osteoarthritis by addressing the root cause rather than just alleviating pain.

What evidence suggests that XytriX might be an effective treatment for knee osteoarthritis?

Research has shown that stem cell therapy can reduce pain and improve joint function in people with osteoarthritis. One study found that patients experienced an average pain reduction of 30-50%. Another study reported rapid improvements, with patients achieving up to 85% of the maximum benefit within three months. MRI scans have shown some knee improvements after treatment. Overall, evidence suggests that stem cell therapy offers a promising option for relieving osteoarthritis symptoms.26789

Are You a Good Fit for This Trial?

This trial is for adults with moderate to severe knee osteoarthritis (pain score ≥7/24, Grade I-IV by X-ray) who have had symptoms for at least 3 months. People can't join if they've recently had major knee surgery, certain injections, other autoimmune diseases like rheumatoid arthritis, active infections or cancer, or are pregnant.

Inclusion Criteria

I have significant knee pain, scoring at least 7 out of 24 on a pain scale.
I am 18 or older and have knee osteoarthritis confirmed by X-ray.
I am not pregnant and will use two forms of birth control during and after treatment.
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Exclusion Criteria

I have had knee surgery or injury on my target knee in the last 6 months.
Suspected or confirmed pregnancy, or planning to become pregnant within 2 years of treatment
Ligament instability (cruciate or collateral ligaments) or ligament laxity of the target knee as judged by the PI
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-articular injections of XytriX at varying doses (10, 30, or 50 million cells) for knee osteoarthritis

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including VAS, KOOS, and other measures

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • XytriX

Trial Overview

The study tests the safety and effectiveness of XytriX—umbilical cord-derived stem cells—by injecting them into the affected knee. Participants will be monitored to see if their pain and function improve compared to standard care.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: XytriX 50 million cells IA doseExperimental Treatment1 Intervention
Group II: XytriX 30 million cells intra-articular injectionExperimental Treatment1 Intervention
Group III: XytriX 10 million cells IA InjectionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

TricelX Inc.

Lead Sponsor

Citations

Outcomes Following Stem Cell-Based Therapies for Hip ...

Pain reduction was consistently observed, with average visual analog scale (VAS) score reductions of 30-50%. Functional improvement was reported ...

TriCelX Receives FDA Study May Proceed Letter for XytriX

TriCelX's RMAT request is grounded in the extensive published body of clinical evidence demonstrating MSC efficacy and safety in knee OA, ...

Stem Cell Therapy for Osteoarthritis · Info for Participants

This study aims to study the safety and efficacy of XytriX, an umbilical cord-derived stem cell product, in the treatment of Grade I-IV knee ...

TriCelX Receives FDA Study May Proceed Letter for XytriX™

TriCelX's RMAT request is grounded in the extensive published body of clinical evidence demonstrating MSC efficacy and safety in knee OA, ...

Stem Cell Therapy for Osteoarthritis Reviewed in MILES ...

Independent radiologists determined that a year after receiving the treatment some patients' knees showed improvement on the MRI. These changes ...

The Safety and Efficacy of XytriX (Umbilical Cord-Derived ...

This study aims to study the safety and efficacy of XytriX, an umbilical cord-derived stem cell product, in the treatment of Grade I-IV knee osteoarthritis.

Clinical efficacy and safety of stem cell therapy for knee ... - PMC

We performed a meta-analysis of the efficacy and safety of stem cell therapy as a clinical treatment of knee osteoarthritis. This meta-analysis is expected ...

Efficacy and Safety of Intra-Articular Cell-Based Therapy for ...

Cell-based therapy had a better effect on KOOS improvement and pain relief without safety concerns. However, cell-based therapy did not show a benefit in terms ...

Mesenchymal Stem Cell Therapy for Knee Osteoarthritis

The study is a multicentered, randomized, double-blinded, placebo-controlled study conducted on the unilateral knee of 120 patients.