NCT05146583

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: New York Presbyterian Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Lumbar Disc Disease

Interventions

Type	Name	Description
PROCEDURE	Autologous bone marrow aspirate injected intradiscal after microdiscectomy	Harvested from SI-joint, 2-5ml BMA is injected in the discectomy defect.
PROCEDURE	Discectomy only	Transflaval discectomy with or without the use of a microtube (according to surgeons' preference).

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-06-01
• Completion: 2023-06-01
• First posted: 2021-12-07
• Last updated: 2021-12-21

Locations

1 site across 1 country: United States