Clinical Trials Logo
  1. Home
  2. Lumbar Disc Disease
  3. NCT05146583

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
See also
  Status Clinical Trial Phase
Completed NCT01941563 - A Study of SI-6603 in Patients With Lumbar Disc Herniation Phase 3
Completed NCT04061759 - Physiotherapy in Lumbar Disc Pathologies N/A
Recruiting NCT04727385 - Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease N/A
Completed NCT04587401 - The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure N/A
Not yet recruiting NCT06034041 - The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study Phase 4
Recruiting NCT04134975 - Evaluation of the Contribution of Intraoperative Scans Coupled With the Navigation for the Precision of the Positioning of the Pedicle Screws During a Lumbar Spine Surgery: a Prospective Randomised Study N/A
Recruiting NCT04641039 - Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis N/A
Completed NCT04301232 - Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy
Recruiting NCT06154005 - OsteoAdapt SP Advanced Bone Graft Feasibility Study - Transforaminal Interbody Lumbar Fusion Phase 1/Phase 2
Completed NCT03977961 - The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.
Enrolling by invitation NCT05444751 - GA + ESP vs. SA + ESP in Lumbar Decompression Surgeries Phase 3
Completed NCT02700451 - Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes N/A
Completed NCT02421601 - A Study of SI-6603 in Patients With Lumbar Disc Herniation Phase 3
Active, not recruiting NCT03733626 - Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease N/A
Recruiting NCT04042844 - A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD) Phase 2
Completed NCT05345249 - Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery Phase 4
Active, not recruiting NCT03060434 - Pentoxifylline and Lumbar Radiculopathy Phase 4
Withdrawn NCT02852187 - Single Center Study Comparing MOBIS II ST vs MOBIS PEEK N/A
Completed NCT04062942 - The Six-Minute Walking Test (6WT) and Timed-Up-and-Go (TUG) Test as Measures of Objective Functional Impairment in Patients Undergoing Interlaminar or Transforaminal Epidural Steroid Injection for Lumbar Degenerative Disc Disease (DDD)
Recruiting NCT03745040 - Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion Phase 4