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
|Condition or disease||Intervention/treatment||Phase|
|Bilateral Primary Osteoarthritis of Knee||Drug: Autologous Bone Marrow Aspirate Concentrate Drug: Sterile saline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|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|
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.
- 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.
- 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.
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
|United States, Florida|
|Mayo Clinic Jacksonville|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Shane Shapiro, MD||Mayo Clinic|