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

NCT06329492 | Completed Phase 1 FDA Drug

• 1 other identifier: 23-007937
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the treatment of knee osteoarthritis (OA).

Conditions

Osteoarthritis; OA; Knee Osteoarthritis

Keywords

regenerative med

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  The number of Adverse Events reported

  1 year

Secondary Outcomes (5)

• Visual Analog Scale (VAS) for Pain

  1 year

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

  1 year

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

  1 year

• Knee Injury and Osteoarthritis Outcome Score (KOOS):

  1 year

• Procedure Recommendation

  1 year

Study Arms (1)

Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP)

EXPERIMENTAL

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

Biological: Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP)

Interventions

Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) BIOLOGICAL

Your blood will be processed into Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) A2MRP in the procedure room with you while you wait. This will take approximately 30 minutes. When this is complete, an ultrasound will be done of your knee to determine the best location for injection into the knee joint. You will undergo an ultrasound guided injection, and the needle guided into the knee joint, and the Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) A2MRP will be injected into the joint space. If there is excessive fluid in your knee, this may be drained before the injection is performed. The needle will be removed, and a band aid will be placed over the injection site.

Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or females,18-65 years of age
• Chronic (\> 3 months), unilaterally symptomatic, primary knee OA.
• Painful knee OA in one or more knee compartments grade 2-3 radiologic severity based upon the Kellgren-Lawrence grading scale, without evidence of advanced (bone on bone, as determined by study investigators) OA in the patellofemoral compartment or on Posterior Anterior (PA) flexion views
• Cognitive ability to give informed consent
• Speak fluent English
• Worst knee pain greater than 4 on a 0-10 pain scale (0 = no pain, 10 = worst pain imaginable)
• Previous 6 week or longer trial of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory medications/acetaminophen or injection therapy (e.g., cortisone)
• Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including blood draw, laboratory tests, diagnostic imaging, and follow-up visits and assessments
• Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure.

You may not qualify if:

• Pregnant or nursing, or planning on becoming pregnant during the study period
• Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study treatment or analysis of the results
• Significant valgus or varus malalignment as determined by investigator
• Injections of any kind into the target knee:
• Corticosteroid injections within 3 months prior to study enrollment
• Hyaluronic acid injections within 6 months prior to study enrollment
• PRP injection within the year prior to study enrollment
• History of BMAC, Micro-Fragmented Adipose Tissue (MFAT), or perinatal product injection at any point
• History of intra-articular infection in the target knee
• History of superficial infection in the target knee within 6 months of study enrollment, or evidence of current superficial infection affecting the target knee
• Body mass index (BMI) \< 35 kg/m2
• Inability to stop non-steroidal anti-inflammatory medications for 1 week before through 2 weeks after the procedure date
• On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids
• Current tobacco product use, including nicotine patch or other nicotine products
• Clinically significant rheumatological or inflammatory disease or chondrocalcinosis/ calcium pyrophosphate disease (CPPD), hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, systemic sclerosis, system lupus erythematosus, and Ehlers-Danlos Syndrome, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Brennan Boettcher, D.O

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single group cohort of 20 subjects

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 26, 2024
• Study Start: January 9, 2024
• Primary Completion: January 28, 2026
• Study Completion: February 6, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)