An observational study in Lumbar Disc Disease, sponsored by New York Presbyterian Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-21.
Sponsored by New York Presbyterian Hospital · Observational
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.
63 studies on the registry are indexed under Intervertebral disc disease; 18 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 22 observational studies indexed under Intervertebral disc disease.
Browse Intervertebral disc disease studies →New York Presbyterian Hospital is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with symptomatic lumbar disc herniation and discogenic back pain who meet the inclusion criteria may be eligible for this procedure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Harvested from SI-joint, 2-5ml BMA is injected in the discectomy defect.
Transflaval discectomy with or without the use of a microtube (according to surgeons' preference).
Change in Numeric Rating for Back pain at 12 months
0 to 10 NRS
Time frame: Baseline, 3 months, 6 months, 12 months after surgery
Change in Oswestry Disability Index at 12 months
0 to 100 PROM to measure low back disfunction
Time frame: Baseline, 3 months, 6 months, 12 months after surgery
Disc Height Index
MRI measurement
Time frame: Baseline and 12 months or longer folllow-up after surgery
Pfirrman grading
MRI measurement
Time frame: Baseline and 12 months or longer folllow-up after surgery
Change in NRS Leg pain
0 to 10 NRS
Time frame: Baseline, 3 months, 6 months, 12 months after surgery
Complications
Infections, reoperations, blood loss.
Time frame: Continrous monitoring during study during one year after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2021 (actual). Primary completion is estimated for Jun 2022, 7 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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New York Presbyterian Hospital