Risks of Intradiscal Orthobiologic Injections: A Review of the Literature and Case Series Presentation.
Mairin A Jerome, Christopher Lutz, Gregory E Lutz
https://pubmed.ncbi.nlm.nih.gov/34376494/Actively Recruiting
Led by Weill Medical College of Cornell University · Updated on 2026-07-29
90
Participants Needed
1
Research Sites
47 weeks
Total Duration
Researchers are studying whether adding a bone marrow aspirate concentrate BMAC injection during lumbar microdiscectomy surgery can improve recovery in adults with lumbar disc herniation. The trial aims to see if the injection leads to better disc tissue health on MRI scans and greater improvement in pain and disability compared to surgery alone. Adults aged 18 and older scheduled for this surgery are eligible to participate. Participants are randomly assigned to receive either the standard lumbar microdiscectomy surgery with a one-time 1-2 cc intradiscal BMAC injection during surgery or the same surgery without the injection. The study compares these two groups to evaluate the effect of the BMAC injection on disc health and recovery outcomes. Participants will have the surgery with or without the injection and complete pain and disability questionnaires at multiple times over two years. MRI scans will be performed at the start and at follow-up visits to assess disc structure and tissue health. Leftover disc or bone marrow tissue samples from surgery will be collected for analysis. Researchers will measure changes in disc hydration, proteoglycan content, disc height, and other imaging and clinical outcomes over 2 years to assess treatment effects.
CONDITIONS
Biologic Injection For Adults With Lumbar Disc Herniation
R
Research Assistant
R
Research Assistant
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Weill Medical College of Cornell University
Lead Sponsor
Aclarion
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | BMAC Injection plus Surgery | Microdiscectomy Alone |
|---|---|---|
| What it is | One-time injection of bone marrow aspirate concentrate into the affected disc during standard lumbar microdiscectomy surgery. | Standard lumbar microdiscectomy surgery performed for herniated lumbar discs, without any intradiscal BMAC injection. |
| Role in the trial | Evaluates whether adding BMAC to surgery changes disc hydration, structure, and patient-reported outcomes compared to surgery alone. | Provides a direct comparison for patients undergoing microdiscectomy without any regenerative cell injection. |
| Primary use | Studied as a regenerative support therapy for enhancing disc repair and tissue health in patients having microdiscectomy for lumbar disc herniation. | Considered standard surgical care for symptomatic lumbar disc herniation failing conservative management. |
| How it is given or performed | Bone marrow is drawn from the patient during surgery, processed to obtain aspirate concentrate, then injected into the affected disc as part of the operative procedure. | Standard lumbar microdiscectomy performed according to common surgical protocols, without any additional intradiscal injection. |
| Evidence status | Early clinical studies suggest potential for symptom improvement and disc regeneration, but larger randomized trials are needed to confirm efficacy and establish long-term benefit. | Surgical decompression using microdiscectomy is supported by established evidence and is routinely effective for relieving leg pain and neurological symptoms due to disc herniation. |
| Important limitations | The safety and durability of BMAC injection are still under study, with unknown long-term risks such as disc infection, inflammation, or unproven clinical benefit over surgery alone. | Standard surgery can lead to recurrent symptoms or re-herniation, and may not restore disc structure or prevent future spine degeneration. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single surgery day
Participants undergo lumbar microdiscectomy surgery with or without a one-time bone marrow aspirate concentrate (BMAC) injection during surgery.
1 surgery visit
Duration - 2 years
Participants complete pain and disability questionnaires and have MRI scans at baseline, 3 months, 1 year, and 2 years after surgery to assess disc health and recovery.
Multiple follow-up visits over 2 years
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Mairin A Jerome, Christopher Lutz, Gregory E Lutz
https://pubmed.ncbi.nlm.nih.gov/34376494/J Mochida, D Sakai, Y Nakamura...
https://pubmed.ncbi.nlm.nih.gov/25794529/Takafumi Yoshikawa, Yurito Ueda, Kiyoshi Miyazaki...
https://pubmed.ncbi.nlm.nih.gov/20421856/David C Noriega, Francisco Ardura, Rubén Hernández-Ramajo...
https://pubmed.ncbi.nlm.nih.gov/33492116/Kenneth A Pettine, Matthew B Murphy, Richard K Suzuki...
https://pubmed.ncbi.nlm.nih.gov/25187512/Kristin Comella, Robert Silbert, Michelle Parlo
https://pubmed.ncbi.nlm.nih.gov/28086781/Lluis Orozco, Robert Soler, Carles Morera...
https://pubmed.ncbi.nlm.nih.gov/21792091/Wentao Zhang, Tianze Sun, Ying Li...
https://pubmed.ncbi.nlm.nih.gov/35148808/Christian Elabd, Christopher J Centeno, John R Schultz...
https://pubmed.ncbi.nlm.nih.gov/27585696/Weill Medical College of Cornell University
Lead Sponsor
Aclarion
Collaborating Sponsor