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Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT02958267
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph Ruane, OhioHealth

Brief Summary:
The purpose of this study is to determine the clinical response to autologous bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee osteoarthritis with respect to pain, function, and quality of life at up to 1 year following the intervention. Specifically, the clinical response will be compared to baseline and a control group treated with a Gel-One® hyaluronate injection to the target knee.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: BMAC injection Biological: PRP injection Device: Gel-One® hyaluronate injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee: Effect on Pain and Quality of Life
Study Start Date : December 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: BMAC injection and PRP injection
Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
Biological: BMAC injection
60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.

Biological: PRP injection
60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.

Active Comparator: Gel-One® hyaluronate injection
Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).
Device: Gel-One® hyaluronate injection
Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.




Primary Outcome Measures :
  1. Knee injury and Osteoarthritis Outcome Score [ Time Frame: Change from baseline to 1 year post-treatment ]

Secondary Outcome Measures :
  1. Numeric Pain Rating Scale [ Time Frame: Change from baseline to 1 year post-treatment ]
  2. Patient Reported Outcome Measurement Information System Global Health scores [ Time Frame: Change from baseline to 1 year post-treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients 40 to 70 years old
  2. Diagnosed with knee osteoarthritis based on the American College of Rheumatology criteria including symptomatic reports and radiographic findings
  3. Kellgren-Lawrence grade 1-3 based on a radiograph within 6 months of presentation to the clinic
  4. Symptomatic evidence of tibiofemoral osteoarthritis for ≥6 months
  5. Average numeric pain rating of 4 - 8 on a scale of zero to 10 (defined as moderate level) over the past week
  6. Previous trial of 6 weeks minimum of conservative therapy including physical therapy, weight loss, anti-inflammatory medication, or injection therapy

Exclusion Criteria:

  1. Grade 4 knee osteoarthritis according to the Kellgren-Lawrence scale
  2. History of intraarticular viscosupplementation or steroid injection in the target knee in the past 6 months at the time of the baseline visit or intraarticular injection planned during the trial
  3. History of arthroscopic surgery in the target knee in the past 12 months at the time of presentation to the clinic or planned surgery during the trial period (e.g., scheduled for/awaiting arthroscopy or a knee replacement procedure)
  4. Bilateral knee osteoarthritis (unless the contralateral knee involvement is limited to radiographic osteoarthritis and not symptomatic)
  5. Ipsilateral (same side) or contralateral (opposite side) symptomatic osteoarthritis of hip or ankle
  6. Clinically apparent tense effusion or other acute inflammation of the target knee at the time of presentation to the clinic
  7. Active infection of either lower extremity such as cellulitis or any skin disease or infection in the area where BMAC is aspirated, blood is drawn, or an injection is given
  8. History of diagnosis of any of the following: 1) septic osteoarthritis of any joint, 2) inflammatory arthropathy such as rheumatoid arthritis, gout, pseudogout, lupus, crystalline arthropathy, chondrocalcinosis and other rheumatology diagnoses
  9. Cruciate/collateral knee ligament instability, ligament laxity, or meniscal instability of the target knee
  10. Significant alignment deformity such as varus/valgus of the target knee in the judgment of the investigator
  11. Currently pregnant, nursing, or planning to become pregnant during the trial period
  12. Previous or known allergic reaction or hypersensitivity to heparin; sodium citrate; hyaluronan products or specifically Gel-One®; cinnamon; bird products such as feathers, eggs, or poultry; avian proteins
  13. Not suitable for BMAC tissue allograft injection per physician (e.g., blood dyscrasia)
  14. Unable to be prescribed stable dose of NSAIDs and/or tramadol based on medical history as ad lib use of over-the-counter analgesics will be allowed in both groups after treatment
  15. Current cigarette smoker
  16. Unable to give informed consent
  17. Non-English speaking

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): NCT02958267


Locations
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United States, Ohio
McConnell Spine, Sport, and Joint Physicians
Columbus, Ohio, United States, 43214
Sponsors and Collaborators
OhioHealth
Investigators
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Principal Investigator: Joseph J Ruane, DO Medical Director, McConnell Heart Health Center

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Responsible Party: Joseph Ruane, Principal Investigator - Medical Director, McConnell Heart Health Center, OhioHealth
ClinicalTrials.gov Identifier: NCT02958267     History of Changes
Other Study ID Numbers: OH1-16-00672
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Keywords provided by Joseph Ruane, OhioHealth:
knee osteoarthritis
regenerative medicine
orthobiologics
cellular therapy

Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents