TTAX03 Injection for Knee Osteoarthritis

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: BioTissue Holdings, Inc

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if a single injection of TTAX03 in saltwater can improve knee conditions better than just saltwater. It targets patients needing knee injections and checks their response over a few months.

Research Team

Eligibility Criteria

Adults aged 35-85 with chronic knee pain and swelling from osteoarthritis (KL grade 3 or 4), who haven't found relief with other treatments like hyaluronic acid or corticosteroids. Participants should have a BMI ≤40, no severe joint diseases besides OA, not be using opioids, and women of childbearing age must use birth control.

Inclusion Criteria

Able to reliably complete the KOOS self-administered questionnaire

I am between 35 and 85 years old, or over 50 if 30 younger participants have already joined.

I am willing to use effective birth control during the study.

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Exclusion Criteria

I've had a knee injury in the last 3 months that made it hard to walk for over a day.

I have had surgery on my knee for ligament repair or bone grafting.

Concurrent treatment, or treatment in the past 90 days, with any investigational agent

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Treatment Details

Interventions

Saline (Other)
TTAX03 (Other)

Trial OverviewThe trial is testing if a single injection of TTAX03 (a treatment derived from human amniotic and umbilical cord tissues) can provide more relief for knee arthritis pain after 12 weeks compared to a saline placebo, based on established responder criteria.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: TTAX03Experimental Treatment1 Intervention

TTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic processing followed by terminal sterilization by gamma irradiation in compliance with current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells. TTAX03 is suspended in a volume of 2.0mL of sterile, preservative free 0.9% NaCl.

Group II: Control: SalinePlacebo Group1 Intervention

2.0mL of sterile, preservative free 0.9% NaCl alone