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Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease.

Lumbar Disc Disease Clinical Trial

Official title:
Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease: a Phase I Clinical Trial

Clinical Trial Summary

Lumbar discectomy and injection of purified cellular bone marrow concentrate or lumbar discectomy only

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05146583
Study type Observational
Source New York Presbyterian Hospital
Contact Roger Hartl, Prof.dr.
Phone (212) 821-0850
Email ermabell@cornell.edu.com
Status Recruiting
Phase
Start date November 1, 2021
Completion date June 1, 2023
View Details
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