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Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration

NCT ID: NCT03014037

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-07

Study Completion Date

2020-06-13

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Keywords

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Orthopedics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Unilateral Bone Marrow Procurement

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Bilateral Bone Marrow Procurement

Intervention Type PROCEDURE

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.

Interventions

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Unilateral Bone Marrow Procurement

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.

Intervention Type PROCEDURE

Bilateral Bone Marrow Procurement

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Mautner

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth Mautner, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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The Emory Clinic

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00093044

Identifier Type: -

Identifier Source: org_study_id