Clinical trial NCT05146583: Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease.
Official title: Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease: a Phase I Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Disc Disease
Keywords: Sciatica
Lumbar Disc Herniation
Discectomy
Lead sponsor: New York Presbyterian Hospital
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptomatic lumbar disc herniation and discogenic back pain who meet the inclusion criteria may be eligible for this procedure.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Numeric Rating for Back pain at 12 months
timeFrame: Baseline, 3 months, 6 months, 12 months after surgery
Secondary outcomes:
measure: Change in Oswestry Disability Index at 12 months
timeFrame: Baseline, 3 months, 6 months, 12 months after surgery
measure: Disc Height Index
timeFrame: Baseline and 12 months or longer folllow-up after surgery
measure: Pfirrman grading
timeFrame: Baseline and 12 months or longer folllow-up after surgery
measure: Change in NRS Leg pain
timeFrame: Baseline, 3 months, 6 months, 12 months after surgery
measure: Complications
timeFrame: Continrous monitoring during study during one year after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbytarian Hospital
state: New York
Study officials:
References: