Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease.

• Conditions: Lumbar Disc Disease

• Registration Number: NCT05146583
• Lead Sponsor: New York Presbyterian Hospital

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.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-22
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Study First Posted: 2021-12-07
• Last Update Posted: 2021-12-21
• Primary Completion: 2022-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Numeric Rating for Back pain at 12 months	Baseline, 3 months, 6 months, 12 months after surgery	0 to 10 NRS

Secondary Outcome Measures

Name	Time	Method
Pfirrman grading	Baseline and 12 months or longer folllow-up after surgery	MRI measurement
Complications	Continrous monitoring during study during one year after surgery	Infections, reoperations, blood loss.
Disc Height Index	Baseline and 12 months or longer folllow-up after surgery	MRI measurement
Change in Oswestry Disability Index at 12 months	Baseline, 3 months, 6 months, 12 months after surgery	0 to 100 PROM to measure low back disfunction
Change in NRS Leg pain	Baseline, 3 months, 6 months, 12 months after surgery	0 to 10 NRS

Trial Locations

Locations (1)

New York Presbytarian Hospital; 🇺🇸 New York, New York, United States