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Stem Cell Therapy

Bone Marrow Cells for Knee Osteoarthritis (ACCELERATE3 Trial)

Phase 3

Waitlist Available

Led By Riam Shamma, MD

Research Sponsored by CELL Technologies Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of osteoarthritis (OA) of one or both knees supported by radiological evidence (Kellgren Lawrence Grade II-IV) assessed locally

Knee pain ≥ 40 mm out of 100 mm on single question VAS at Screening and prior to Randomization

Must not have

Knee surgery in the previous 6 months prior to enrollment

Concomitant inflammatory disease or other condition affecting the joints

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to determine the effect of ia injection(s) of autologous bmac in promoting health economic outcomes, compared to controls

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to determine if injecting a person's own bone marrow cells into their knee(s) is more effective than the standard treatment for knee osteoarthritis.

Who is the study for?

This trial is for individuals with mild to severe knee osteoarthritis, which is a type of joint disease causing pain and stiffness. Participants will receive treatment in one or both knees.

What is being tested?

The ACCELERATE3 trial tests the effectiveness of a single injection of Bone Marrow Aspirate Concentrate (BMAC) compared to standard care injections in reducing knee arthritis symptoms.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, swelling, infection risk, and temporary increase in pain following the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with knee osteoarthritis, confirmed by X-rays.

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My knee pain is at least 40 on a scale of 100.

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I am not pregnant.

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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had knee surgery within the last 6 months.

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I have a condition that causes joint inflammation.

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I have a significant knee deformity due to a disease.

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I don't have pain elsewhere that could affect my knee pain evaluation.

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I do not have an active infection or a history of HIV, hepatitis, or syphilis.

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I have had a knee replacement surgery, either partial or total, on one or both knees.

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I am scheduled for knee replacement surgery within the next 6 months.

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I am currently on blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline in womac® total score (section a, b, and c, items #1-24) as measured by vas at 1, 4, 24, 36, and 48-weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline in womac® total score (section a, b, and c, items #1-24) as measured by vas at 1, 4, 24, 36, and 48-weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline in womac® total score (section a, b, and c, items #1-24) as measured by vas at 1, 4, 24, 36, and 48-weeks. for reporting.