Clinical trial NCT03014037: Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
Official title: Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Orthopedics
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects nearly 27 million people in the United States. This disease leads to the breakdown of the cartilage surfaces of the joints, which serve as the connection points between the bones of the body, causing a large amount of pain and disability in patients. Increasing the number of available treatment options for osteoarthritis is becoming increasingly more important as Americans continue to age. Using stem cells taken from bone marrow is one of the non-operative treatments that has been gaining popularity in the recent past. This study aims to clarify how this procedure should best be done by comparing stem cell concentrations and patient outcomes (short and long term) in patients who have stem cells taken from one area vs two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).

Detailed description: Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects nearly 27 million people in the United States. This disease leads to the breakdown of the cartilage surfaces of the joints, which serve as the connection points between the bones of the body, causing a large amount of pain and disability in patients. Increasing the number of available treatment options for osteoarthritis is becoming increasingly more important as Americans continue to age. Using stem cells taken from bone marrow is one of the non-operative treatments that has been gaining popularity in the recent past. This study aims to clarify how this procedure should best be done by comparing stem cell concentrations and patient outcomes (short and long term) in patients who have stem cells taken from one area vs two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).

This research study involves the participant being randomly placed into one of two groups; one group will have cells taken from one hip, and the other will have cells taken from both hips. Both of these approaches are performed in clinics currently, and both are considered to be standard of care. All bone marrow collected for the purposes of this study will be obtained by the principal investigator while performing the standard procedure. In obtaining these sample the physicians will abide by the standard of care set forth for the Bone Marrow Aspiration Concentrate procedure.

Eligibility criteria: Inclusion Criteria:

* Currently scheduled for a bone marrow aspirate concentration (BMAC) procedure
* Cognitively able to give consent and complete the required questionnaires

Exclusion Criteria:

* History of leukemia or lymphoma
* History of any autoimmune disorders and disease
* Currently taking immunosuppressive medications
* Presence of an active or suspected infection, or an infection of the joint in question within the past 6 months
* Vulnerable populations (pregnant women and breast-feeding women)
* Cortisone injection into the affected joint within 6 weeks
* Used NSAIDs within 1 week of the procedure
* History of bleeding disorders or inflammatory joint disease
* Surgical intervention on the affected or contralateral joint within 6 months of BMAC injection

Primary outcomes:
measure: Change Quality of Life assessed by the Emory Quality of Life (EQOL) Survey Score
timeFrame: Pre-treatment, Follow Up (Up to One Year)
measure: Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Pre-treatment, Follow Up (Up to One Year)
Secondary outcomes:
measure: Capacity of Isolated Cells to Differentiate Down Cell Lineages
timeFrame: Post Cell Culture (Up to 21 Days)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Kenneth Mautner, MD
role: PRINCIPAL_INVESTIGATOR
References: