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Recruiting NCT04716803

NCT04716803 Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

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Clinical Trial Summary
NCT ID NCT04716803
Status Recruiting
Phase
Sponsor University of California, San Diego
Condition Osteo Arthritis Knee
Study Type INTERVENTIONAL
Enrollment 10 participants
Start Date 2020-07-08
Primary Completion 2023-12-31

Eligibility & Interventions

Sex All sexes
Min Age 45 Years
Max Age 75 Years
Study Type INTERVENTIONAL
Interventions
Bone Marrow Aspirate ConcentrateAngel Concentrated Platelet Rich Plasma (cPRP) System

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 10 participants in total. It began in 2020-07-08 with a primary completion date of 2023-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The purpose of this study is to investigate the safety and effectiveness of bone marrow aspirate concentrate (BMAC) in patients with moderate to severe osteoarthritis of the knee. BMAC provides a rich source of mesenchymal stem cells (MSCs) and is a stem cell-based therapy that has been reported to preserve or improve the structure of joints. The Angel System is the device used in this study to concentrate bone marrow from the patient and is intended to separate a mixture of blood and bone marrow and collect plasma rich platelets preoperative to a surgical procedure. The goal of this study is to identify whether BMAC can be an effective and safe treatment for patients with osteoarthritis of the knee.

Eligibility Criteria

Inclusion Criteria: 1. Kellgren Lawrence radiographic grade IV 2. Need for a total knee arthroscopy by the patients primary care provider/or orthopedist. 3. Persistent pain in target knee that is unresponsive to standard of care including acetametaphine, non-steroidal anti-inflammatory drugs, physical therapy and/or intraarticular corticosteroids and/or hyaluronic acid preparations. 4. Males or females aged 45-75. Exclusion Criteria: \-

Contact & Investigator

Central Contact

Kenneth Kalunian, MD

✉ kkalunian@health.ucsd.edu

📞 858-246-2381

Frequently Asked Questions

Who can join the NCT04716803 clinical trial?

This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Osteo Arthritis Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04716803 currently recruiting?

Yes, NCT04716803 is actively recruiting participants. Contact the research team at kkalunian@health.ucsd.edu for enrollment information.

Where is the NCT04716803 trial being conducted?

This trial is being conducted at La Jolla, United States.

Who is sponsoring the NCT04716803 clinical trial?

NCT04716803 is sponsored by University of California, San Diego. The trial plans to enroll 10 participants.

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