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

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Emory University

Status

Completed

Conditions

Osteoarthritis

Treatments

Procedure: Unilateral Bone Marrow Procurement
Procedure: Bilateral Bone Marrow Procurement

Study type

Interventional

Funder types

Other

Identifiers

NCT03014037
IRB00093044

Details and patient eligibility

About

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).

Full 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.

Enrollment

35 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 2 patient groups

Unilateral Procurement of Bone Marrow
Other group
Description:
Participants currently scheduled to undergo a bone marrow aspirate concentration (BMAC) procedure will be randomized to unilateral procurement of bone marrow.
Treatment:
Procedure: Unilateral Bone Marrow Procurement
Bilateral Bone Marrow Procurement
Experimental group
Description:
Participants currently scheduled to undergo a bone marrow aspirate concentration (BMAC) procedure will be randomized to bilateral procurement of bone marrow.
Treatment:
Procedure: Bilateral Bone Marrow Procurement

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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