Bone Marrow Concentrate for Herniated Disc

(BMAC Trial)

Overseen By Research Assistant

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Active malignancy, Infection, Autoimmune disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether injecting bone marrow concentrate (BMAC) during lumbar disc surgery can improve recovery for individuals with herniated discs. Specifically, it examines whether the injection enhances disc health and reduces pain and disability compared to surgery alone. Participants will receive either the surgery with the BMAC injection or just the surgery, and their progress will be monitored over two years. Suitable candidates are those who have unsuccessfully tried other treatments for their herniated disc for more than three months and are scheduled for surgery. As an unphased trial, this study provides patients the opportunity to contribute to groundbreaking research that could enhance recovery options for herniated discs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the BMAC injection is safe for lumbar microdiscectomy patients?

Research has shown that bone marrow aspirate concentrate (BMAC) injections can be relatively safe for treating lower back disc issues. In one study, patients who received these injections reported less back pain for up to a year, indicating the treatment is generally well-tolerated. Another study examined changes in physical function after the injection and found no major safety concerns.

Although few studies exist, BMAC appears to have a good safety record, with no major reports of serious side effects. BMAC uses the patient's own cells, which can lower the risk of complications. Prospective participants should consult their healthcare provider to understand the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for herniated discs, which typically involve physical therapy, pain medications, or surgery, Bone Marrow Aspirate Concentrate (BMAC) is unique because it leverages the body’s own healing mechanisms. Researchers are excited about BMAC because it involves injecting concentrated bone marrow cells directly into the affected disc area during surgery, potentially speeding up recovery and enhancing healing. This approach is particularly promising as it could reduce the need for more invasive procedures and lower the risk of complications associated with traditional surgeries.

What evidence suggests that the BMAC injection could be an effective treatment for herniated disc?

Research has shown that bone marrow aspirate concentrate (BMAC) injections can reduce pain and improve movement in individuals with lower back disc problems. In this trial, participants in the BMAC group will receive a BMAC injection during lumbar microdiscectomy surgery. Studies have found that injecting BMAC into the disc can significantly lessen pain, with some patients experiencing up to 60% improvement over several years. This treatment appears to shrink the bulging disc, easing pressure and pain. BMAC uses stem cells from the patient's own body, which may aid in healing and tissue repair. Overall, early results are promising, suggesting that BMAC could enhance recovery after lower back disc surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Roger Hartl, MD

Principal Investigator

NewYork Presbyterian-Weill Cornell Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for lumbar microdiscectomy due to a herniated disc in the lower back. It's not specified, but typically participants should be in good general health and not have conditions that would interfere with surgery or recovery.

Inclusion Criteria

My condition hasn't improved after 3 months of non-surgical treatment.

I am 18 years old or older.

I have been diagnosed with a spinal condition requiring surgery.

Exclusion Criteria

I have an autoimmune disorder affecting my lower back.

I currently have an ongoing infection.

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo lumbar microdiscectomy surgery with or without BMAC injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including MRI scans and questionnaires

2 years

Multiple visits over 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Bone Marrow Aspirate Concentrate (BMAC)

Trial Overview

The study is testing if adding a bone marrow aspirate concentrate (BMAC) injection during lumbar microdiscectomy surgery can improve disc tissue health and reduce pain/disability more than surgery alone. Participants will be monitored via MRI scans and questionnaires over two years.

How Is the Trial Designed?

Group I: BMAC Group Active Control 1 Intervention

Administration of one 1-2cc intradiscal Bone Marrow Aspirate Concentrate (BMAC) injection during lumbar microdiscectomy surgery.

Group II: Control Group Active Control 1 Intervention

Standard of care lumbar microdiscectomy surgery without the BMAC injection.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Aclarion

Industry Sponsor

Trials

1

Recruited

300+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7410505/

Systematic Review: Is Intradiscal Injection of Bone Marrow ...

Intradiscal injection of BMC for lumbar disc degeneration resulted in statistically significant improvement in VAS and ODI with low re-injection and ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07386548

Biologic Injection For Adults With Lumbar Disc Herniation

The goal of this clinical trial is to find out whether adding a bone-marrow aspirate concentrate (BMAC) injection during surgery can improve ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9590351/

The Analgesic Efficacy of Intradiscal Injection of Bone Marrow ...

Our synthesis revealed that generally intradiscal autologous or allogeneic BMAC and culture-expanded BM-MSCs improved discogenic pain compared to baseline.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666548422000981

Comprehensive narrative review on the analysis of ...

Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 months. Stem Cells, 33 (2015), pp ...

5.

mdpi.com

mdpi.com/2227-9059/13/10/2365

Long-Term Effectiveness of Intradiscal Culture-Expanded ...

also published results of 33 patients treated with a similar protocol showing an average improvement of 60% over 6 years, and 85% had a reduction in disc bulge ...

6.

scitechnol.com

scitechnol.com/peer-review-pdfs/efficacy-and-safety-of-stem-cells-in-standalone-lumbar-interbody-fusion-for-recurrent-disc-herniations-RwqN.pdf

efficacy-and-safety-of-stem-cells-in-standalone-lumbar- ...

Objective: This study aimed to evaluate the therapeutic effectiveness and safety of allogeneic stem cell injections in the.