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Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease: a Phase I Clinical Trial
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
New York Presbytarian Hospital
New York, New York, United States
Start Date
November 1, 2021
Primary Completion Date
June 1, 2022
Completion Date
June 1, 2023
Last Updated
December 21, 2021
60
ESTIMATED participants
Autologous bone marrow aspirate injected intradiscal after microdiscectomy
PROCEDURE
Discectomy only
PROCEDURE
Lead Sponsor
New York Presbyterian Hospital
NCT04641039
NCT02192112
NCT04984213
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