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

Primary Purpose

Degenerative Disc Disease, Spine Degeneration

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection

About this trial

This is an interventional treatment trial for Degenerative Disc Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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

Exclusion Criteria:

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.
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

Sites / Locations

Bone and Joint Clinic of Baton Rouge

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BMAC Injection

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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?"

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

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.

Full Information

NCT ID

NCT03912454

First Posted

April 10, 2019

Last Updated

March 15, 2022

Sponsor

Bone and Joint Clinic of Baton Rouge

1. Study Identification

Unique Protocol Identification Number

NCT03912454

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 8, 2019 (Actual)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bone and Joint Clinic of Baton Rouge

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Disc Disease, Spine Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BMAC Injection

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection

Intervention Description

Subjects will undergo bone marrow aspiration from the iliac crest. Bone marrow will be concentrated and injected into the symptomatic lumbar disc.

Primary Outcome Measure Information:

Title

Change in Visual Analog Scale (VAS) Pain Score

Description

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.

Time Frame

1 day (Pre-injection) to 12 months post-injection

Title

Change in Oswestry Disability Index

Description

Time Frame

1 day (Pre-injection) to 12 months post-injection

Secondary Outcome Measure Information:

Title

BMAC injection survival

Description

Time Frame

12 months post-injection

Title

MRI evaluation of the degenerative disc

Description

A modified Pfirrman grade will be assigned and used to assess changes in the disc pre-injection to 1 year post - injection

Time Frame

1 day (Pre-injection) and 12 months post-injection

Title

CFU-F Analysis

Description

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.

Time Frame

1 Day of Injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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 Exclusion Criteria: 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. 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

Facility Information:

Facility Name

Bone and Joint Clinic of Baton Rouge

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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