Biologic Injection For Adults With Lumbar Disc Herniation

Официальное название

Bone Marrow Aspirate Concentrate Injection With MRI's - A Prospective Randomized Control Trial

Обзор

The goal of this clinical trial is to find out whether adding a bone-marrow aspirate concentrate (BMAC) injection during surgery can improve recovery in adults undergoing lumbar microdiscectomy for a lumbar disc herniation. The main questions it aims to answer are: * Does the BMAC injection lead to better disc tissue health after surgery (as seen on MRI scans)? * Does the BMAC injection lead to greater improvement in pain and disability compared to surgery alone? Participants will be adults aged 18 and older who are scheduled for lumbar microdiscectomy surgery. Researchers will compare one group of participants receiving the standard-of-care surgery plus the BMAC injection with another group receiving the same surgery without the injection to see if the injection offers added benefit. Participants will: * Have surgery (microdiscectomy) with or without the injection. * Complete pain and disability questionnaires at several times over 2 years. * Undergo MRI scans at baseline and follow-up to assess disc structure and tissue health. * Provide samples of leftover disc or bone-marrow tissue (as applicable) from surgery for analysis.

Вмешательства

• Другое Bone Marrow Aspirate Concentrate (BMAC)
  Dosage Form: Autologous intradiscal injection Dosage: 1-2 cc's Frequency: Once, during surgery Duration: N/A

Первичные конечные точки

• Change from Baseline in Intervertebral Disc Hydration at 3 Months [Срок оценки: Baseline and 3 Months post-operation]
• Change from Baseline in Intervertebral Disc Hydration at 1 Year [Срок оценки: Baseline and 1 year post-operation]
• Change from Baseline in Intervertebral Disc Hydration at 2 Years [Срок оценки: Baseline and 2 years post-operation]
• Change from Baseline in Proteoglycan Content at 3 Months [Срок оценки: From enrollment to 3 Months post-operation]
• Change from Baseline in Proteoglycan Content at 1 Year [Срок оценки: From enrollment to 1 year post-operation]
• Change from Baseline in Proteoglycan Content at 2 Years [Срок оценки: From enrollment to 2 years post-operation]
• Change from Baseline in Disc Height Index at 3 Months [Срок оценки: From enrollment to 3 months post-operation]
• Change from Baseline in Disc Height Index at 1 Year [Срок оценки: From enrollment to 1 year post-operation]
• Change from Baseline in Disc Height Index at 2 Years [Срок оценки: From enrollment to 2 years post-operation]
• Change from Baseline in Pfirrmann Grade at 3 Months [Срок оценки: From enrollment to 3 months post-operation]

Вторичные конечные точки (11)

• Change from Baseline in Patient Reported Pain at 3 Months [Срок оценки: From enrollment to 3 Months post-operation]
• Change from Baseline in Patient Reported Pain at 6 Months [Срок оценки: From enrollment to 6 Months post-operation]
• Change from Baseline in Patient Reported Pain at 1 Year [Срок оценки: From enrollment to 1 Year post-operation]
• Change from Baseline in Patient Reported Pain at 2 Years [Срок оценки: From enrollment to 2 years post-operation]
• Change from Baseline in Patient Reported Disability at 3 Months [Срок оценки: From enrollment to 3 Months post-operation]
• Change from Baseline in Patient Reported Disability at 6 Months [Срок оценки: From enrollment to 6 Months post-operation]
• Change from Baseline in Patient Reported Disability at 1 Year [Срок оценки: From enrollment to 1 year post-operation]
• Change from Baseline in Patient Reported Disability at 2 Years [Срок оценки: From enrollment to 2 years post-operation]
• Change from Baseline in SI-Score at 3 Months [Срок оценки: From enrollment to 3 months post-operation]
• Change from Baseline in SI-Score at 1 Year [Срок оценки: From enrollment to 1 year post-operation]
• Change from Baseline in SI-Score at 2 Years [Срок оценки: From enrollment to 2 years post-operation]

Критерии участия

Критерии включения

• Male or female patients ≥ 18 years of age
• Clinically and/or radiographically (MRI) confirmed diagnosis of degenerative disc disease of the lumbar spine, lumbar disc herniation, and indication for lumbar microdiscectomy surgery
• Unresponsive to conservative/non-operative treatment for >3 months
• Psychosocial, mental and physical ability to understand and to adhere to this protocol, especially adhering to the visit schedule follow-ups and observe the treatment plan

Критерии исключения

• Prisoners
• Individuals who are not yet adults (infants, children, teenagers)
• Individuals who are not able to clearly understand English
• Adults with diminished capacity to consent
• Major cognitive impairment causing to inability to understand and provide informed consent
• Active malignancy
• Active chronic or acute infection
• Autoimmune disorder that impacts the lumbar spine (ankylosing spondylitis, lupus e.g.)
• Bone marrow-derived or non-bone marrow-derived cancer
• Low platelet count or clotting disorders
• Prior surgery at the level to be treated or the adjacent level

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• NewYork-Presbyterian/Weill Cornell Medical Center — Manhattan

Публикации

• Zhang W, Sun T, Li Y, Yang M, Zhao Y, Liu J, Li Z. Application of stem cells in the repair of intervertebral disc degeneration. Stem Cell Res Ther. 2022 Feb 11;13(1):70. doi: 10.1186/s13287-022-02745-y. PMID 35148808
• Elabd C, Centeno CJ, Schultz JR, Lutz G, Ichim T, Silva FJ. Intra-discal injection of autologous, hypoxic cultured bone marrow-derived mesenchymal stem cells in five patients with chronic lower back pain: a long-term safety and feasibility study. J Transl Med. 2016 Sep 1;14(1):253. doi: 10.1186/s12967-016-1015-5. PMID 27585696
• Mochida J, Sakai D, Nakamura Y, Watanabe T, Yamamoto Y, Kato S. Intervertebral disc repair with activated nucleus pulposus cell transplantation: a three-year, prospective clinical study of its safety. Eur Cell Mater. 2015 Mar 20;29:202-12; discussion 212. doi: 10.22203/ecm.v029a15. PMID 25794529
• Noriega DC, Ardura F, Hernandez-Ramajo R, Martin-Ferrero MA, Sanchez-Lite I, Toribio B, Alberca M, Garcia V, Moraleda JM, Gonzalez-Vallinas M, Sanchez A, Garcia-Sancho J. Treatment of Degenerative Disc Disease With Allogeneic Mesenchymal Stem Cells: Long-term Follow-up Results. Transplantation. 2021 Feb 1;105(2):e25-e27. doi: 10.1097/TP.0000000000003471. No abstract available. PMID 33492116
• Jerome MA, Lutz C, Lutz GE. Risks of Intradiscal Orthobiologic Injections: A Review of the Literature and Case Series Presentation. Int J Spine Surg. 2021 Apr;15(s1):26-39. doi: 10.14444/8053. Epub 2021 Apr 21. PMID 34376494
• Pettine KA, Murphy MB, Suzuki RK, Sand TT. Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 months. Stem Cells. 2015 Jan;33(1):146-56. doi: 10.1002/stem.1845. PMID 25187512
• Yoshikawa T, Ueda Y, Miyazaki K, Koizumi M, Takakura Y. Disc regeneration therapy using marrow mesenchymal cell transplantation: a report of two case studies. Spine (Phila Pa 1976). 2010 May 15;35(11):E475-80. doi: 10.1097/BRS.0b013e3181cd2cf4. PMID 20421856
• Orozco L, Soler R, Morera C, Alberca M, Sanchez A, Garcia-Sancho J. Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study. Transplantation. 2011 Oct 15;92(7):822-8. doi: 10.1097/TP.0b013e3182298a15. PMID 21792091

Идентификаторы

NCT: NCT07386548 · 24-09027977

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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