Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease.
NCT ID: NCT05146583
Last Updated: 2021-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2021-11-01
2023-06-01
Brief Summary
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Detailed Description
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The use of mesenchymal stem cells for regeneration of degenerated connective tissue of mesenchymal origin has proven efficient in multiple recent studies. However, the acquisition of mesenchymal stem cells (MSC) is always an extensive procedure requiring either enzymatic or genetic manipulation of acquired tissues. Thus, the use of these MSCs is highly controversial and raises concerns in terms of patient safety.
One of the most commonly used sources for MSCs is bone marrow tissue. Even when not manipulated, these tissues already contain a significant amount of mesenchymal stem cells and growth factors. Therefore, they are used for regenerative treatments of multiple degenerative musculoskeletal diseases.
This is an exploratory pilot study which aims to compare patient outcomes between two treatments approaches for DDD that are currently being used in clinic. While micro- discectomy is the standard of care for DDD, micro-discectomies with autologous bone marrow cell injections have been used in clinic in the past year. The goal of this study is to determine if the bone marrow injection group is superior compared to the control group (state of the art micro-discectomies) in enhancing degenerative disc recovery and improving or preventing back pain.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Autologous bone marrow aspirate injected intradiscal after microdiscectomy
Harvested from SI-joint, 2-5ml BMA is injected in the discectomy defect.
Discectomy only
Transflaval discectomy with or without the use of a microtube (according to surgeons' preference).
Eligibility Criteria
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Inclusion Criteria
2. Radiologically (MRI) confirmed diagnosis degenerative disc disease of the lumbar spine and/or lumbar disc herniation
3. Unresponsive to conservative/non-operative treatment for \>3 months
4. Psychosocial, mental and physical ability to understand and to adhere to this protocol, especially adhering to the visit schedule follow-ups, and observe treatment plan
5. Signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial study-related procedures
Exclusion Criteria
2. Active malignancy
3. Active chronic or acute infection
4. Autoimmune disorder that impacts the lumbar spine (Ankylosing spondylitis, lupus eg.)
5. Acute Episode or major mental illness
6. Major cognitive impairment causing to inability to understand informed consent
18 Years
ALL
No
Sponsors
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New York Presbyterian Hospital
OTHER
Responsible Party
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Pravesh Gadjradj
on behalf of PI: Prof.dr.R.Hartl, chief of spine surgery
Locations
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New York Presbytarian Hospital
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Pravesh S Gadjradj, MD
Role: primary
Brendan Mendary, BS
Role: backup
Other Identifiers
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NYP19-04020103
Identifier Type: -
Identifier Source: org_study_id