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

NCT03014037 | Completed

• 1 other identifier: IRB00093044
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis

Keywords

Orthopedics

Outcome Measures

Primary Outcomes (2)

• Change Quality of Life assessed by the Emory Quality of Life (EQOL) Survey Score

  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)

  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 Outcomes (1)

• Capacity of Isolated Cells to Differentiate Down Cell Lineages

  Post Cell Culture (Up to 21 Days)

Study Arms (2)

Unilateral Procurement of Bone Marrow

OTHER

Participants currently scheduled to undergo a bone marrow aspirate concentration (BMAC) procedure will be randomized to unilateral procurement of bone marrow.

Procedure: Unilateral Bone Marrow Procurement

Bilateral Bone Marrow Procurement

EXPERIMENTAL

Participants currently scheduled to undergo a bone marrow aspirate concentration (BMAC) procedure will be randomized to bilateral procurement of bone marrow.

Procedure: Bilateral Bone Marrow Procurement

Interventions

Unilateral Bone Marrow Procurement 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.

Unilateral Procurement of Bone Marrow

Bilateral Bone Marrow Procurement 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.

Bilateral Bone Marrow Procurement

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kenneth Mautner, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 9, 2017
• Study Start: September 7, 2017
• Primary Completion: June 13, 2020
• Study Completion: June 13, 2020
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

US (1)