Lumbar Disc Disease Clinical Trial
Official title:
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
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 1, 2023 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male or female patients =18 years of age 2. Radiologically (MRI) confirmed diagnosis degenerative disc disease of the lumbar spine and/or lumbar disc herniation 3. Unresponsive to conservative/non-operative treatment for >3 months 4. Psychosocial, mental and physical ability to understand and to adhere to this protocol, especially adhering to the visit schedule follow-ups, and observe treatment plan 5. Signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial study-related procedures Exclusion Criteria: 1. Pregnant or breastfeeding patients 2. Active malignancy 3. Active chronic or acute infection 4. Autoimmune disorder that impacts the lumbar spine (Ankylosing spondylitis, lupus eg.) 5. Acute Episode or major mental illness 6. Major cognitive impairment causing to inability to understand informed consent |
Country | Name | City | State |
---|---|---|---|
United States | New York Presbytarian Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York Presbyterian Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Numeric Rating for Back pain at 12 months | 0 to 10 NRS | Baseline, 3 months, 6 months, 12 months after surgery | |
Secondary | Change in Oswestry Disability Index at 12 months | 0 to 100 PROM to measure low back disfunction | Baseline, 3 months, 6 months, 12 months after surgery | |
Secondary | Disc Height Index | MRI measurement | Baseline and 12 months or longer folllow-up after surgery | |
Secondary | Pfirrman grading | MRI measurement | Baseline and 12 months or longer folllow-up after surgery | |
Secondary | Change in NRS Leg pain | 0 to 10 NRS | Baseline, 3 months, 6 months, 12 months after surgery | |
Secondary | Complications | Infections, reoperations, blood loss. | Continrous monitoring during study during one year after surgery |
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 | |
Recruiting |
NCT06462729 -
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
|
Phase 1/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)
|