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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 26, 2013
First Posted Date  ICMJE August 29, 2013
Last Update Posted Date May 5, 2017
Study Start Date  ICMJE August 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01931007 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis
Official Title  ICMJE Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis, A Randomized Placebo Controlled Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Bilateral Primary Osteoarthritis of Knee
Intervention  ICMJE
  • 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.
  • Drug: Sterile saline
    Bacteriostatic 0.9% sodium chloride, preservative free manufactured by Hospira will be injected into the control knee.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Autologous Bone Marrow Aspirate Concentrate
  • 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.
    Intervention: Drug: Sterile saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2013)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01931007
Other Study ID Numbers  ICMJE 12-004459
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shane A. Shapiro, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shane Shapiro, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP