Degenerative Disc DiseaseNCT03912454

A Prospective Study of Clinical Outcomes Following a Single Intradiscal Injection of Bone Marrow Aspirate Concentrate (BMAC) for Single Level Discogenic Low Back Pain

A study testing Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection in people with Degenerative Disc Disease and Spine Degeneration, run by Bone and Joint Clinic of Baton Rouge at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This single-institution prospective case series (single arm) study will assess the clinical outcomes of patients diagnosed with 1 or 2 level level discogenic low back pain following an intradiscal injection of bone marrow aspirate concentrate (BMAC). Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Degenerative Disc Disease, Spine Degeneration
What is being tested?: Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 8 Apr 2019to Sep 2022
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Ages 18 to 60 years
Symptomatic discogenic low back pain, clinically demonstrated by a loss of lumbar range of motion and pain to deep palpation over the symptomatic disc.
MRI confirmed single level lumbar disc height loss <50% (Modified Pfirrman grade <=7).
MRI confirmed isolated lumbar disc degeneration OR
o If zygapophysial joint degeneration is present on MRI, subject must have failed intra-articular injection or medial branch block (<50% pain relief) to be eligible for enrollment. PI will have final discretion as to whether the patient's symptoms originate from a single disc.
Patient must have completed at least 3 months conservative treatment. Conservative treatment may include NSAIDs or Acetaminophen when medically appropriate and physiotherapy, chiropractic care, or a guided home exercise program.

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BMI < 40
Back pain greater than leg pain with back pain rating on a 100 mm visual analog scale (VAS) >= 40 mm
Pain Catastrophizing Scale <= 30

Who cannot join

Prior fusion at the level to be treated
>2 levels requiring intervention
Non discogenic source of back pain
Intradural disc herniation
Full thickness annular tear at the index level.
Lumbar spine surgery within the past 6 months.

Show all 17Show fewer

Pregnant or breastfeeding.
Known allergy or sensitivity to heparin or citrate (used for processing BMAC)
Coagulopathy preventing spinal injection
Active infection
Malignancy within past 5 years other than basal cell or squamous cell skin cancer.
Severe uncontrolled medical condition
Other significant pain generator that may affect the subject's answers to PRO questionnaires.
Current Tobacco use
Pending litigation involving subject's back pain
Incarcerated at the time of study enrollment
Inability to give informed consent for study participation for any reason

Trial locations and contacts

1 site in 1 country.

United States1 site

Bone and Joint Clinic of Baton Rouge
Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Read the detailed description

Background:

BMAC is a cellular rich fraction of bone marrow aspirate that can be readily prepared at the point of care without additional processing steps to manipulate or isolate cells. In addition, BMAC contains growth factors from the peripheral blood which may promote disc healing.

Study Summary:

The study population will consist of up to 20 patients aged 18- 60 with unresolved low back pain attributable to intervertebral disc degeneration. Clinical exam will indicate the intervertebral disc as the source of pain with features such as midline pain, pain upon rising from a seated position, or positive responses to centralization maneuvers. Moderate single level lumbar disc (L1-S1) degeneration (<50% disc height) will be confirmed on MRI. Other low back pain generators must be eliminated prior to study enrollment. Subjects must meet minimum score criteria on baseline PROs (VAS>=40 and ODI>=30). Subjects that meet all of the inclusion and none of the exclusion criteria will be invited to participate in the study.

Enrolled subjects will undergo bone marrow aspiration and intradiscal injection by an experienced orthopedic spine surgeon. Subjects will be followed for 1 year to evaluate the effects of the disc injection.

Conditions: Degenerative Disc Disease, Spine Degeneration
Being tested: Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous Bone Marrow Aspirate Concentrate (BMAC) InjectionOther
Subjects will undergo bone marrow aspiration from the iliac crest. Bone marrow will be concentrated and injected into the symptomatic lumbar disc.

Study groups in NCT03912454
Study group	Role	What they receive
BMAC Injection	Experimental	Not described Receives: Other: Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Visual Analog Scale (VAS) Pain Score
The severity of back and leg pain will be evaluated using a 100 mm visual analog scale (VAS) where a higher number indicates greater pain.
Measured: 1 day (Pre-injection) to 12 months post-injection
Change in Oswestry Disability Index
The Oswestry Disability Index (ODI) is the most commonly used patient reported outcome measure in patients with low back pain. The ODI score ranges from 0% to 100%. A higher score corresponds to a greater disability.
Measured: 1 day (Pre-injection) to 12 months post-injection

Secondary outcomes (3)

BMAC injection survival
The number of subjects who do not proceed to surgery for their discogenic back pain and answer YES to " Are you satisfied with the outcome of this injection? OR NO to "Are you seeking any additional treatments for your discogenic back pain at this time?"
Measured: 12 months post-injection
MRI evaluation of the degenerative disc
A modified Pfirrman grade will be assigned and used to assess changes in the disc pre-injection to 1 year post - injection
Measured: 1 day (Pre-injection) and 12 months post-injection
CFU-F Analysis
Cell viability testing and CFU-F assay will be conducted on an aliquot from each subject's BMAC. Number of CFU-F from each patient will be used to correlate with patient reported outcomes.
Measured: 1 Day of Injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 2019Sep 2022

First posted11 Apr 2019
Study start8 Apr 2019
Primary completionSep 2022 (estimated)
Study completionSep 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03912454
Sponsor's protocol ID: BMAC1601
Status last verified: Mar 2022
First submitted: 10 Apr 2019
Last updated: 16 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study of Clinical Outcomes Following a Single Intradiscal Injection of Bone Marrow Aspirate Concentrate (BMAC) for Single Level Discogenic Low Back Pain
ClinicalTrials.gov ID: NCT03912454
Acronym / sponsor ID: BMAC1601
Conditions: Degenerative Disc Disease, Spine Degeneration
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 20 participants (estimated)
Lead sponsor: Bone and Joint Clinic of Baton RougeUniversity, hospital or other
Study start: 8 Apr 2019 (actual)
Primary completion: Sep 2022 (estimated)
Study completion: Sep 2022 (estimated)
First posted: 11 Apr 2019 (actual)
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.

Detailed description

Background:

Study Summary:

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BMAC Injection	Experimental	Other: Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Ages 18 to 60 years
Symptomatic discogenic low back pain, clinically demonstrated by a loss of lumbar range of motion and pain to deep palpation over the symptomatic disc.
MRI confirmed single level lumbar disc height loss <50% (Modified Pfirrman grade <=7).
MRI confirmed isolated lumbar disc degeneration OR
o If zygapophysial joint degeneration is present on MRI, subject must have failed intra-articular injection or medial branch block (<50% pain relief) to be eligible for enrollment. PI will have final discretion as to whether the patient's symptoms originate from a single disc.

Key exclusion criteria (17 listed)

Prior fusion at the level to be treated
>2 levels requiring intervention
Non discogenic source of back pain
Intradural disc herniation
Full thickness annular tear at the index level.

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
Autologous Bone Marrow Aspirate Concentrate (BMAC) InjectionSubjects will undergo bone marrow aspiration from the iliac crest. Bone marrow will be concentrated and injected into the symptomatic lumbar disc.	Other	BMAC Injection

Primary outcome

Change in Visual Analog Scale (VAS) Pain Score
Time frame: 1 day (Pre-injection) to 12 months post-injection
The severity of back and leg pain will be evaluated using a 100 mm visual analog scale (VAS) where a higher number indicates greater pain.
Change in Oswestry Disability Index
Time frame: 1 day (Pre-injection) to 12 months post-injection
The Oswestry Disability Index (ODI) is the most commonly used patient reported outcome measure in patients with low back pain. The ODI score ranges from 0% to 100%. A higher score corresponds to a greater disability.

3 secondary outcomes

BMAC injection survival
Time frame: 12 months post-injection
MRI evaluation of the degenerative disc
Time frame: 1 day (Pre-injection) and 12 months post-injection
CFU-F Analysis
Time frame: 1 Day of Injection

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.

Related trials for Degenerative Disc Disease

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
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Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
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Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 16 Mar 2022. 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?

Results are not available in the source record.

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 in Visual Analog Scale (VAS) Pain Score (time frame: 1 day (Pre-injection) to 12 months post-injection). 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?

On the ClinicalTrials.gov record for NCT03912454.

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 16 Mar 2022.