Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis

Phase 1

Completed

• Conditions: Bilateral Primary Osteoarthritis of Knee
• Interventions: Drug: Autologous Bone Marrow Aspirate Concentrate; Drug: Sterile saline

• Registration Number: NCT01931007
• Lead Sponsor: Mayo Clinic

Brief Summary

The overall goal of this study is to develop regenerative cell therapy for use in patients with osteoarthritis (OA). The primary objective of this proposal is to conduct a pilot study that assesses the safety and feasibility of using concentrated bone marrow aspirate containing MSC to treat patients with painful knee OA.

Detailed Description

Patients with symptomatic mild to moderate bilateral knee osteoarthritis will be candidates for this pilot study. Baseline data includes radiographs, MRI imaging, clinical data on knee pain and analysis of synovial fluid inflammatory markers. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the bone marrow concentrate. The contralateral knee will be injected with only sterile saline for placebo. Follow-up analysis of synovial fluid will be at one week and 6 months after injection; clinical data will be obtained at 3, 6 and 12 months and MRI imaging will be performed at 6 months after injection, with repeat radiographs at 12 months

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-29
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Male and Female subjects are both eligible
2. Subjects must be 18 years of age or older
3. Subjects must have bilateral OA and pain in both knees.
4. Osteoarthritis may be primary or secondary. Knees must have Kellgren-Lawrence Grades 1-3.
5. Subjects must have previously tried 6 weeks of one of the following conservative treatments Activity modification, weight loss; physical therapy, anti-inflammatory or injection therapy
6. Patients can provide written informed consent after the nature of the study is fully explained

Exclusion Criteria

1. Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.
2. Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit.
3. Patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry.
4. Patients receiving injections to the treated knee within 2 months prior to study entry.
5. Patients who are pregnant or currently breast-feeding children.
6. Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
7. Patients with ongoing infectious disease, including HIV and hepatitis
8. Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
9. Patients participating in a study of an experimental drug or medical device within 30 days of study entry.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous bone marrow concentrate	Autologous Bone Marrow Aspirate Concentrate	Subjects with symptomatic mild to moderate bilateral knee osteoarthritis will be enrolled in this study. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the autologous bone marrow aspirate concentrate. The contralateral knee will be injected with only sterile saline for placebo.
Placebo	Sterile saline	Subjects with symptomatic mild to moderate bilateral knee osteoarthritis will be enrolled in this study. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the bone marrow concentrate. The contralateral knee will be injected with only sterile saline for placebo.

Primary Outcome Measures

Name	Time	Method
Number of Subjects with Adverse Reactions to Concentrated Mesenchymal Stem Cells (MSCs)	1 year	Occurrence of adverse reactions to concentrated MSCs from bone marrow aspiration injected into knee joints.

Secondary Outcome Measures

Name	Time	Method
Mean Knee Cartilage	baseline, 6 months, 1 year	Knee cartilage status will be measured prior to injection, at 6 months following injection, and at 12 months following injection. The cartilage will be measured by MRI at baseline and 6 months using MRI and cartilage sequencing techniques, and knee radiographs at 12 months.

Trial Locations

Locations (1)

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States