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Stem Cell Therapy

Bone Marrow Aspirate Concentrate (BMAC) for 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

Timeline

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.

Awards & highlights

ACCELERATE3 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.Check my eligibility

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.See study design

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.

ACCELERATE3 Trial 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.

ACCELERATE3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline in womac® stiffness subscore (section b, items #6-7) as measured by vas at 1, 4, 24, 36, and 48-weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline in womac® stiffness subscore (section b, items #6-7) 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® stiffness subscore (section b, items #6-7) as measured by vas at 1, 4, 24, 36, and 48-weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

SF-12

Safety (Baseline to Day 30 post IA injection)

Six Minute Walk Test

+5 more

Other outcome measures

Exploratory - Economic

Exploratory - SF-12

Exploratory - WOMAC® Pain Subscore

+3 more

ACCELERATE3 Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Autologous Bone Marrow Aspirate Concentrate

2013

Completed Phase 1

~30

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

CELL Technologies Inc.Lead Sponsor

Riam Shamma, MDPrincipal InvestigatorCELL Technologies Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the level of safety associated with Bone Marrow Aspirate Concentrate (BMAC) when used in patient treatment?

"The safety rating for Bone Marrow Aspirate Concentrate (BMAC) is deemed to be a 3 on the scale of 1 to 3 by our team at Power. This assessment is based on the fact that this trial is in Phase 3, indicating both efficacy and multiple rounds of data supporting its safety."

Answered by AI

Are researchers currently seeking participants for this study?

"Based on the information available on clinicaltrials.gov, this particular clinical trial is not currently accepting new participants. Its initial posting was made on April 1st, 2024 and it underwent its most recent update on January 11th, 2024. However, there are presently a total of 713 other active trials actively seeking eligible candidates for enrollment at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bone Marrow Aspirate Concentrate (BMAC) Treatment for Knee Osteoarthritis

2024. "Bone Marrow Aspirate Concentrate (BMAC) Treatment for Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06216028.

All > Knee Osteoarthritis