Lumbar discectomy and injection of purified cellular bone marrow concentrate or lumbar discectomy only
In order to find a regenerative treatment for back pain from DDD, cell based therapies have become of increasing interest. Recent clinical studies have shown promising improvement in pain and disc hydration, thus indicating a regenerative effect. 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.
Study Type
OBSERVATIONAL
Enrollment
60
Harvested from SI-joint, 2-5ml BMA is injected in the discectomy defect.
Transflaval discectomy with or without the use of a microtube (according to surgeons' preference).
New York Presbytarian Hospital
New York, New York, United States
RECRUITINGChange in Numeric Rating for Back pain at 12 months
0 to 10 NRS
Time frame: Baseline, 3 months, 6 months, 12 months after surgery
Change in Oswestry Disability Index at 12 months
0 to 100 PROM to measure low back disfunction
Time frame: Baseline, 3 months, 6 months, 12 months after surgery
Disc Height Index
MRI measurement
Time frame: Baseline and 12 months or longer folllow-up after surgery
Pfirrman grading
MRI measurement
Time frame: Baseline and 12 months or longer folllow-up after surgery
Change in NRS Leg pain
0 to 10 NRS
Time frame: Baseline, 3 months, 6 months, 12 months after surgery
Complications
Infections, reoperations, blood loss.
Time frame: Continrous monitoring during study during one year after surgery
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