Lumbar Disc DiseaseNCT05146583
Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease.
An observational study of Lumbar Disc Disease, run by New York Presbyterian Hospital at 1 site in United States.
Trial summary
Lumbar discectomy and injection of purified cellular bone marrow concentrate or lumbar discectomy only Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Disease
- What is being tested?
- Autologous bone marrow aspirate injected intradiscal after microdiscectomy and Discectomy only
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic lumbar disc herniation and discogenic back pain who meet the inclusion criteria may be eligible for this procedure.
Who may be able to join
- Male or female patients ≥18 years of age
- Radiologically (MRI) confirmed diagnosis degenerative disc disease of the lumbar spine and/or lumbar disc herniation
- Unresponsive to conservative/non-operative treatment for >3 months
- 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
- 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
Who cannot join
- Pregnant or breastfeeding patients
- Active malignancy
- Active chronic or acute infection
- Autoimmune disorder that impacts the lumbar spine (Ankylosing spondylitis, lupus eg.)
- Acute Episode or major mental illness
- Major cognitive impairment causing to inability to understand informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York Presbytarian Hospital
New York, New York, 10021
Pravesh S Gadjradj, MD, 212-821-0850, psg4001@med.cornell.edu
Brendan Mendary, BS, (212) 821-0850, brm4011@med.cornell.edu
About this study
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
Read the 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
- Being tested
- Autologous bone marrow aspirate injected intradiscal after microdiscectomy, Discectomy only
- Keywords
- Sciatica, Lumbar Disc Herniation, Discectomy
- Medical subject headings
- Intervertebral disc disease, Sciatica, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow aspirate injected intradiscal after microdiscectomyProcedure or surgery
Harvested from SI-joint, 2-5ml BMA is injected in the discectomy defect.
Discectomy onlyProcedure or surgery
Transflaval discectomy with or without the use of a microtube (according to surgeons' preference).
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Rating for Back pain at 12 months
0 to 10 NRS
Measured: Baseline, 3 months, 6 months, 12 months after surgery
Secondary outcomes (5)
Change in Oswestry Disability Index at 12 months
0 to 100 PROM to measure low back disfunction
Measured: Baseline, 3 months, 6 months, 12 months after surgery
Disc Height Index
MRI measurement
Measured: Baseline and 12 months or longer folllow-up after surgery
Pfirrman grading
MRI measurement
Measured: Baseline and 12 months or longer folllow-up after surgery
Change in NRS Leg pain
0 to 10 NRS
Measured: Baseline, 3 months, 6 months, 12 months after surgery
Complications
Infections, reoperations, blood loss.
Measured: Continrous monitoring during study during one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start1 Nov 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pravesh Gadjradj, New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146583
- Sponsor's protocol ID
- NYP19-04020103
- Status last verified
- Dec 2021
- First submitted
- 10 Nov 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease: a Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT05146583
- Acronym / sponsor ID
- NYP19-04020103
- Conditions
- Lumbar Disc Disease
- Keywords
- Sciatica, Lumbar Disc Herniation, Discectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- New York Presbyterian HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic lumbar disc herniation and discogenic back pain who meet the inclusion criteria may be eligible for this procedure.
Key inclusion criteria (5 listed)
- Male or female patients ≥18 years of age
- Radiologically (MRI) confirmed diagnosis degenerative disc disease of the lumbar spine and/or lumbar disc herniation
- Unresponsive to conservative/non-operative treatment for >3 months
- 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
- 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
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding patients
- Active malignancy
- Active chronic or acute infection
- Autoimmune disorder that impacts the lumbar spine (Ankylosing spondylitis, lupus eg.)
- Acute Episode or major mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous bone marrow aspirate injected intradiscal after microdiscectomyHarvested from SI-joint, 2-5ml BMA is injected in the discectomy defect. | Procedure or surgery | – |
| Discectomy onlyTransflaval discectomy with or without the use of a microtube (according to surgeons' preference). | Procedure or surgery | – |
Primary outcome
Change in Numeric Rating for Back pain at 12 months
Time frame: Baseline, 3 months, 6 months, 12 months after surgery
0 to 10 NRS
5 secondary outcomes
Change in Oswestry Disability Index at 12 months
Time frame: Baseline, 3 months, 6 months, 12 months after surgery
Disc Height Index
Time frame: Baseline and 12 months or longer folllow-up after surgery
Pfirrman grading
Time frame: Baseline and 12 months or longer folllow-up after surgery
Change in NRS Leg pain
Time frame: Baseline, 3 months, 6 months, 12 months after surgery
Complications
Time frame: Continrous monitoring during study during one year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Disease, run by New York Presbyterian Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roger Hartl, Prof.dr. ((212) 821-0850, ermabell@cornell.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Rating for Back pain at 12 months (time frame: Baseline, 3 months, 6 months, 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.