Recruiting

BMAC

Sponsor:

UCLA

Code:

NCT04716803

Conditions

Osteo Arthritis Knee

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Bone Marrow Aspirate Concentrate

Angel Concentrated Platelet Rich Plasma (cPRP) System

Study Details

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.

Conditions

Osteo Arthritis Knee

Study ID

NCT04716803

Start date

Jul 8, 2020

Status verified date

Jan, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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:

-

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bone marrow aspiration concentrate using the Angel System

Bone marrow aspirate concentrate (BMAC) will be administered via injection to the knee of interest on day 14 of the study.

Bone marrow aspiration will be concentrated using the Angel System.

Interventions

Bone Marrow Aspirate Concentrate

Aspiration of bone marrow will be collected from the patient's pelvic bone region and subsequently concentrated with the Angel Concentrated Platelet Rich Plasma (cPRP) System.

Angel Concentrated Platelet Rich Plasma (cPRP) System

Aspiration of bone marrow will be collected from the patient's pelvic bone region and subsequently concentrated with the Angel Concentrated Platelet Rich Plasma (cPRP) System.

Primary outcome measure

  • Patients with at least one severe adverse event [ Time Frame: End of Study (12 months) ]

Central Contacts and Locations

Central contacts

Kenneth Kalunian, MD

858-246-2381kkalunian@health.ucsd.edu

Locations

University of California San Diego Koman Outpatient Pavilion

Recruiting

La Jolla, California, United States, 92037

Contacts

Karen Cuervo, BS

858-249-3038kcuervo@health.ucsd.edu

Principal Investigator:

Kenneth Kalunian, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Jan 26, 2022

Last verified

Jan, 2022

Keywords

  • moderate to severe knee osteoarthritis
  • total knee replacement
  • bone marrow
  • stem cell-based therapy
  • arthroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2022-01-26.