Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis

NCT01931007 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 12-004459
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Bilateral Primary Osteoarthritis of Knee

Keywords

osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Number of Subjects with Adverse Reactions to Concentrated Mesenchymal Stem Cells (MSCs)

  Occurrence of adverse reactions to concentrated MSCs from bone marrow aspiration injected into knee joints.

  1 year

Secondary Outcomes (1)

• Mean Knee Cartilage

  baseline, 6 months, 1 year

Study Arms (2)

Autologous bone marrow concentrate

EXPERIMENTAL

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.

Drug: Autologous Bone Marrow Aspirate Concentrate

Placebo

PLACEBO COMPARATOR

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.

Drug: Sterile saline

Interventions

Autologous Bone Marrow Aspirate Concentrate 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.

Autologous bone marrow concentrate

Sterile saline DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female subjects are both eligible
• Subjects must be 18 years of age or older
• Subjects must have bilateral OA and pain in both knees.
• Osteoarthritis may be primary or secondary. Knees must have Kellgren-Lawrence Grades 1-3.
• 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
• Patients can provide written informed consent after the nature of the study is fully explained

You may not qualify if:

• Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.
• Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit.
• Patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry.
• Patients receiving injections to the treated knee within 2 months prior to study entry.
• Patients who are pregnant or currently breast-feeding children.
• 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.
• Patients with ongoing infectious disease, including HIV and hepatitis
• Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
• Patients participating in a study of an experimental drug or medical device within 30 days of study entry.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Related Publications (2)

• 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.

  PMID: 27566242 RESULT

• 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.

  PMID: 27515308 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Shane Shapiro, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Consultant

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: August 29, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

US (1)