- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03014037
Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- The Emory Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Unilateral Procurement of Bone Marrow
Participants currently scheduled to undergo a bone marrow aspirate concentration (BMAC) procedure will be randomized to unilateral procurement of bone marrow.
|
A total of 61cc of bone marrow will be procured under ultrasound guidance from one posterior superior iliac spine (PSIS) via 3 passes, each at least 1 cm apart, through the bone cortex.
In each pass, investigators will obtain 2.3cc of BMA with a 60cc syringes.
|
EXPERIMENTAL: Bilateral Bone Marrow Procurement
Participants currently scheduled to undergo a bone marrow aspirate concentration (BMAC) procedure will be randomized to bilateral procurement of bone marrow.
|
30.5cc of bone marrow will be obtained under ultrasound guidance from each posterior superior iliac spine (PSIS) with 3 passes, at least 1 cm apart, per side (10.17cc per pass) using 60cc syringes.
The collection from each PSIS will be combined to yield a total of 61cc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Quality of Life assessed by the Emory Quality of Life (EQOL) Survey Score
Time Frame: Pre-treatment, Follow Up (Up to One Year)
|
The EQOL survey measures five dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The participant will be asked to answer questions regarding these measures and to indicate their current experience on a scale from 1 to 3; 1 being "no problem" and 3 being "most extreme problem".
The answers to these question are put together to create a 5 digit composite score.This composite score can be indexed to a lookup table which produces a single summary score from 0 to 100.
The lookup table we use is weighted and normalized to the United Stated general population.
|
Pre-treatment, Follow Up (Up to One Year)
|
Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Pre-treatment, Follow Up (Up to One Year)
|
The KOOS questionnaire is an instrument to assess the patient's opinion about their osteoarthritis and associated problems.
It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL).
Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
A total lower score indicates more problems.
|
Pre-treatment, Follow Up (Up to One Year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Capacity of Isolated Cells to Differentiate Down Cell Lineages
Time Frame: Post Cell Culture (Up to 21 Days)
|
Bone marrow aspirate will be placed in 10 mL heparinized tubes and nucleated cells will be isolated with a density gradient and re-suspended in complete culture medium for plating.
Isolated adherent cells will be processed for the ability to differentiate down osteogenic-, adipogenic- and chondrogenic-lineage after cell harvest.
Specifically, isolated cells are treated with different media to induce their differentiation into 1) osteo-progenitor cells (identified by positive staining with Alzarian red, 2) adipocytes (identified by positive staining with Oil-Red) and 3) chondrocytes (identified by positive staining with Alcian blue).
The presence of these phenotypes should be prevalent by 3 weeks; if not, the cells are not considered pluripotent for that lineage and hence would not be classified as mesenchymal stem cells.
|
Post Cell Culture (Up to 21 Days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kenneth Mautner, MD, Emory University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00093044
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
-
Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
-
University Hospital, LilleCompleted
-
Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on Unilateral Bone Marrow Procurement
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid System NeoplasmUnited States
-
Johns Hopkins UniversityON FoundationNot yet recruitingRotator Cuff TearsUnited States
-
University of Wisconsin, MadisonNational Heart, Lung, and Blood Institute (NHLBI)CompletedGraft Versus Host Disease (GVHD) | Acute Myocardial Infarction (AMI)United States
-
Zimmer BiometTerminatedPeripheral Arterial Disease | Peripheral Vascular Disease | Critical Limb IschemiaUnited States
-
Zimmer BiometNo longer availablePeripheral Arterial Disease | Peripheral Vascular Diseases | Critical Limb IschemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI); Incuron LLCRecruitingRefractory Lymphoma | Refractory Malignant Solid Neoplasm | Recurrent Lymphoma | Recurrent Malignant Solid Neoplasm | Recurrent Osteosarcoma | Refractory Osteosarcoma | Diffuse Midline Glioma, H3 K27M-Mutant | Recurrent Diffuse Intrinsic Pontine Glioma | Metastatic Malignant Neoplasm in the Central... and other conditionsUnited States
-
Andrews Research & Education FoundationFloridaRecruitingRotator Cuff Tear or Rupture, Not Specified as TraumaticUnited States
-
Postgraduate Institute of Medical Education and...Completed
-
AldagenCompletedPeripheral Arterial Disease | Peripheral Vascular Disease | Critical Limb IschemiaUnited States
-
Medical College of WisconsinRecruitingBone Marrow Biopsy ProcedureUnited States