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Biological

Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) for Osteoarthritis (A2MRP Trial)

Phase 1 & 2

Waitlist Available

Led By Brennan Boettcher, D.O

Research Sponsored by Mayo Clinic

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 1 year

Awards & highlights

A2MRP Trial Summary

This trial aims to see if injections of a person's own plasma rich in alpha-2 macroglobulin can help with knee osteoarthritis.

Who is the study for?

This trial is for adults aged 18-65 with moderate knee osteoarthritis, experiencing pain greater than 4 on a scale of 0-10. Participants must have tried conservative treatments for over six weeks and be fluent in English. Excluded are pregnant individuals, those with recent infections or surgeries in the target knee, BMI over 35, significant knee deformity or alignment issues, chronic immunosuppression, or current tobacco/nicotine use.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of A2MRP injections directly into the knee to treat symptoms of osteoarthritis. It aims to see if this treatment can reduce pain and improve joint function compared to standard therapies.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site such as pain, swelling or infection; however specific side effects related to A2MRP are not detailed but will be monitored throughout the study.

A2MRP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adverse Events

Secondary outcome measures

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Pain interference

Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Physical function

+2 more

A2MRP Trial Design

1Treatment groups

Experimental Treatment

Group I: Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP)Experimental Treatment1 Intervention

Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) is produced by filtering Platelet Poor Plasma (PPP), a Platelet Rich Plasma byproduct, through a hemoconcentrator filter. (PPP) is frequently used in clinical practice to increase volume of PRP or Bone Marror Aspirate Concentrate (BMAC) injectate, and it is occasionally injected in isolation for some indication

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,209 Previous Clinical Trials

3,767,130 Total Patients Enrolled

28 Trials studying Osteoarthritis

2,830 Patients Enrolled for Osteoarthritis

Brennan Boettcher, D.OPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

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

Are individuals currently eligible to participate in this research study?

"Per clinicaltrials.gov, the ongoing recruitment of participants for this trial commenced on 1/9/2024 and was last revised on 3/18/2024."

Answered by AI

What is the collective count of individuals actively involved in this research trial?

"Indeed, the details on clinicaltrials.gov indicate an ongoing search for suitable candidates to partake in this study. The trial was publicly disclosed on January 9th, 2024, and last revised on March 18th of the same year. Recruitment is underway to enlist a total of 20 individuals from one designated site."

Answered by AI

Do I meet the criteria to participate in this research project?

"To participate in this medical research, individuals must have osteoarthritis and fall between the ages of 18 and 65. The trial is open to approximately 20 eligible candidates."

Answered by AI

Is this clinical trial open solely to individuals who have reached adulthood?

"Participants aged between 18 and 65 are sought for enrollment in this research study. It is noteworthy that there exist 33 investigations involving individuals under the age of majority, while there are as many as 640 studies catering to those above the specified upper age limit."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autologous Alpha-2 Macroglobulin Rich Plasma, Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis

Brennan J. Boettcher 2024. "Autologous Alpha-2 Macroglobulin Rich Plasma, Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06329492.

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