Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis

NCT ID: NCT01931007

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-01-31

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

Conditions

Bilateral Primary Osteoarthritis of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Autologous bone marrow 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.

Group Type: EXPERIMENTAL

Autologous Bone Marrow Aspirate Concentrate

Intervention Type: DRUG

Autologous Bone marrow aspirate will be concentrated using Magellan Cell Separator and stem cell kit according to the Standard Operating Procedures is to be injected in the treatment knee. 5ml of treatment cells will be combined with 10 ml of previously separated platelet poor bone marrow plasma and used for injection under ultrasound guidance into one of the subject's painful knees.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Sterile saline

Intervention Type: DRUG

Bacteriostatic 0.9% sodium chloride, preservative free manufactured by Hospira will be injected into the control knee.

Interventions

Autologous Bone Marrow Aspirate Concentrate

Autologous Bone marrow aspirate will be concentrated using Magellan Cell Separator and stem cell kit according to the Standard Operating Procedures is to be injected in the treatment knee. 5ml of treatment cells will be combined with 10 ml of previously separated platelet poor bone marrow plasma and used for injection under ultrasound guidance into one of the subject's painful knees.

Intervention Type: DRUG

Sterile saline

Bacteriostatic 0.9% sodium chloride, preservative free manufactured by Hospira will be injected into the control knee.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Shane A. Shapiro

Orthopedic Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shane Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Countries

United States

References

Shapiro SA, Kazmerchak SE, Heckman MG, Zubair AC, O'Connor MI. A Prospective, Single-Blind, Placebo-Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis. Am J Sports Med. 2017 Jan;45(1):82-90. doi: 10.1177/0363546516662455. Epub 2016 Sep 30.

Reference Type: RESULT

PMID: 27566242 (View on PubMed)

Camilleri ET, Gustafson MP, Dudakovic A, Riester SM, Garces CG, Paradise CR, Takai H, Karperien M, Cool S, Sampen HJ, Larson AN, Qu W, Smith J, Dietz AB, van Wijnen AJ. Identification and validation of multiple cell surface markers of clinical-grade adipose-derived mesenchymal stromal cells as novel release criteria for good manufacturing practice-compliant production. Stem Cell Res Ther. 2016 Aug 11;7(1):107. doi: 10.1186/s13287-016-0370-8.

Reference Type: DERIVED

PMID: 27515308 (View on PubMed)

Other Identifiers

12-004459

Identifier Type: -

Identifier Source: org_study_id