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BMAC vs Corticosteroids for Osteoarthritis (BMAC Trial)

N/A

Recruiting

Led By Jorge Chahla, MD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment up to 6 months postoperatively (12 months if crossover from arm 3 to arm 1)

Awards & highlights

BMAC Trial Summary

This trial will test how BMAC affects knee osteoarthritis patients' reported well-being. Patient's won't know which treatment they're receiving.

Who is the study for?

This trial is for adults aged 18-70 with moderate knee osteoarthritis pain (KL grade 2-3) that persists despite treatments like exercise, weight loss, or painkillers. They must have a pain score of at least 4 and not have had recent knee injections. Those with post-traumatic arthritis, diabetes, cancer, infections or other systemic diseases cannot participate.Check my eligibility

What is being tested?

The study compares the effects of corticosteroid injections versus bone marrow aspirate concentrate (BMAC), which is derived from the patient's own bone marrow. Participants are randomly assigned to one treatment and their reported outcomes are tracked over time.See study design

What are the potential side effects?

Corticosteroid injections may cause joint infection, nerve damage, thinning of nearby bone or soft tissue and temporary flare of joint pain. BMAC side effects could include pain at the extraction site but generally has fewer risks as it uses the patient's own cells.

BMAC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment up to 6 months postoperatively (12 months if crossover from arm 3 to arm 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment up to 6 months postoperatively (12 months if crossover from arm 3 to arm 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment up to 6 months postoperatively (12 months if crossover from arm 3 to arm 1) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Intermittent and Constant Osteoarthritis Pain (ICOAP)

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Visual analogue scale (VAS) for pain

BMAC Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Crossover GroupExperimental Treatment1 Intervention

Any patient in the corticosteroid injection group that shows no improvement in pain after 24 weeks (12 month follow-up if crossover), per physician discretion, will be allowed crossover to the BMAC injection group (ARM 3).

Group II: Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injectionsExperimental Treatment1 Intervention

Autologous bone marrow aspirate concentrate (BMAC) will be removed from the subject knee body with a needle, processed and concentrated by an FDA-approved centrifuge (separator) system. The concentrated cells will be injected into the subject knee. "Autologous" means that the subject is receiving back their own cells that were collected.

Group III: Corticosteroid injectionActive Control1 Intervention

Corticosteroid injection group (ARM 2) will receive a sham incision.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,401 Total Patients Enrolled

25 Trials studying Osteoarthritis

3,138 Patients Enrolled for Osteoarthritis

Jorge Chahla, MDPrincipal InvestigatorRush University Medical Center Associate Professor and Surgeon

1 Previous Clinical Trials

140 Total Patients Enrolled

Media Library

BMAC (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05985785 — N/A

Osteoarthritis Research Study Groups: Corticosteroid injection, Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections, Crossover Group

Osteoarthritis Clinical Trial 2023: BMAC Highlights & Side Effects. Trial Name: NCT05985785 — N/A

BMAC (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05985785 — N/A

Frequently Asked Questions

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

Is there any way to become involved in this experiment?

"In order to be suitable for this medical trial, applicants must have osteoarthritis and encompass an age range of 18-70. Approximately 100 individuals are being sought out for participation in the study."

Answered by AI

Are there still opportunities to join this experiment?

"Data from clinicaltrials.gov denotes that this scientific experiment is currently recruiting participants, having first being listed on July 19th 2022 and last updated in August 2nd 2023."

Answered by AI

Is eligibility for this experiment limited to adults aged 18 or above?

"The requirements for participation in this medical trial are that the patient must be between 18 and 70 years old. This is a relatively small cohort, as there are 35 studies specifically focusing on individuals under 18 years of age and 644 concentrating on those above 65."

Answered by AI

How many individuals are taking part in this medical experiment?

"Affirmative. The information provided on clinicaltrials.gov validates that the enrolment process for this investigation has begun; it was initially posted on July 19th 2022 and updated lastly on August 2nd 2023. A total of 100 persons are needed to be recruited from one single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

2022. "Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05985785.