Bone Marrow Cells for Knee Osteoarthritis
(ACCELERATE3 Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRiam Shamma, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: CELL Technologies Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of the ACCELERATE3 trial is to assess the efficacy of a single intra-articular (IA) injection of autologous BMAC, in one or both knees, compared to a single IA injection of Standard of Care (SOC) in patients with mild to severe knee OA.

Eligibility Criteria

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.

Inclusion Criteria

Willing to provide written informed consent

Able to communicate satisfactorily with the investigator and comply with study requirements

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

+5 more

Exclusion Criteria

I have had knee surgery within the last 6 months.

I have a condition that causes joint inflammation.

I have a significant knee deformity due to a disease.

+8 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Bone Marrow Aspirate Concentrate (BMAC)Experimental Treatment1 Intervention

Cell suspension for infusion. 50 mL of Bone Marrow Aspirate collected, and 10-15 mL BMAC injected to knee(s)

Group II: Standard of CareActive Control1 Intervention

Standard of care IA injection may include cortisone or hyaluronic acid (HA) as per discretion of the Principal Investigator