OsteoarthritisNCT03014037
Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
A study testing Unilateral Bone Marrow Procurement and Bilateral Bone Marrow Procurement in people with Osteoarthritis, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Unilateral Bone Marrow Procurement and Bilateral Bone Marrow Procurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2017to 13 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently scheduled for a bone marrow aspirate concentration (BMAC) procedure
- Cognitively able to give consent and complete the required questionnaires
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Unilateral Bone Marrow Procurement, Bilateral Bone Marrow Procurement
- Keywords
- Orthopedics
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Bone Marrow ProcurementProcedure or surgery
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 ProcurementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Bilateral Bone Marrow Procurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre-treatment, Follow Up (Up to One Year)
Secondary outcomes (1)
Capacity of Isolated Cells to Differentiate Down Cell Lineages
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.
Measured: Post Cell Culture (Up to 21 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start7 Sep 2017
- Primary completion13 Jun 2020
- Study completion13 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Mautner, Emory University
- Investigators
- Kenneth Mautner, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014037
- Sponsor's protocol ID
- IRB00093044
- Status last verified
- Dec 2021
- First submitted
- 5 Jan 2017
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
- ClinicalTrials.gov ID
- NCT03014037
- Acronym / sponsor ID
- IRB00093044
- Conditions
- Osteoarthritis
- Keywords
- Orthopedics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 13 Jun 2020 (actual)
- Study completion
- 13 Jun 2020 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral Procurement of Bone Marrow | Other | Procedure: Unilateral Bone Marrow ProcurementParticipants currently scheduled to undergo a bone marrow aspirate concentration (BMAC) procedure will be randomized to unilateral procurement of bone marrow. |
| Bilateral Bone Marrow Procurement | Experimental | Procedure: Bilateral Bone Marrow ProcurementParticipants currently scheduled to undergo a bone marrow aspirate concentration (BMAC) procedure will be randomized to bilateral procurement of bone marrow. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently scheduled for a bone marrow aspirate concentration (BMAC) procedure
- Cognitively able to give consent and complete the required questionnaires
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral Bone Marrow ProcurementA 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. | Procedure or surgery | Unilateral Procurement of Bone Marrow |
| Bilateral Bone Marrow Procurement30.5cc 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. | Procedure or surgery | Bilateral Bone Marrow Procurement |
Primary outcome
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.
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.
1 secondary outcome
Capacity of Isolated Cells to Differentiate Down Cell Lineages
Time frame: Post Cell Culture (Up to 21 Days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Mautner, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Bone Marrow Procurement and Bilateral Bone Marrow Procurement in people with Osteoarthritis, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.