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

Lumbar Disc Disease Clinical Trial

Official title:

Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease: a Phase I Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146583
• Other study ID #: NYP19-04020103
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: December 2021
• Source: New York Presbyterian Hospital
• Contact: Roger Hartl, Prof.dr.
• Phone: (212) 821-0850
• Email: ermabell[@]cornell.edu.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Lumbar discectomy and injection of purified cellular bone marrow concentrate or lumbar discectomy only

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Disc Disease
• Spinal Diseases

Intervention

Procedure:
• Autologous bone marrow aspirate injected intradiscal after microdiscectomy
Harvested from SI-joint, 2-5ml BMA is injected in the discectomy defect.
• Discectomy only
Transflaval discectomy with or without the use of a microtube (according to surgeons' preference).

Locations

Country	Name	City	State
United States	New York Presbytarian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

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