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Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis (BMAC)

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ClinicalTrials.gov Identifier: NCT01931007
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Shane A. Shapiro, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bilateral Primary Osteoarthritis of Knee Drug: Autologous Bone Marrow Aspirate Concentrate Drug: Sterile saline Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis, A Randomized Placebo Controlled Pilot Study
Study Start Date : August 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 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.
Placebo Comparator: 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.
 Drug: Sterile saline
Bacteriostatic 0.9% sodium chloride, preservative free manufactured by Hospira will be injected into the control knee.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects with Adverse Reactions to Concentrated Mesenchymal Stem Cells (MSCs) [ Time Frame: 1 year ]
    Occurrence of adverse reactions to concentrated MSCs from bone marrow aspiration injected into knee joints.


Secondary Outcome Measures :
  1. Mean Knee Cartilage [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931007


Locations
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United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Shane Shapiro, MD Mayo Clinic
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shane A. Shapiro, Orthopedic Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01931007     History of Changes
Other Study ID Numbers: 12-004459
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shane A. Shapiro, Mayo Clinic:
osteoarthritis

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases