Stem Cell Therapy for Osteoarthritis

Overseen By Kathryn Dziedzic, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: TricelX Inc.

Must not be taking: Systemic steroids, Cytotoxic drugs

Disqualifiers: Pregnancy, BMI over 40, Autoimmune diseases, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

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.

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

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

How Is the Trial Designed?

Group I: XytriX 50 million cells IA dose Experimental Treatment 1 Intervention

Group II: XytriX 30 million cells intra-articular injection Experimental Treatment 1 Intervention

Subjects in this arm are receiving the drug at a 30 million cells IA dose.

Group III: XytriX 10 million cells IA Injection Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

TricelX Inc.

Lead Sponsor