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

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

Study Overview

• Status: Recruiting
• Conditions: Lumbar Disc Disease
• Intervention / Treatment: Procedure: Autologous bone marrow aspirate injected intradiscal after microdiscectomy; Procedure: 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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Roger Hartl, Prof.dr.; Phone Number: (212) 821-0850; Email: ermabell@cornell.edu.com
• Study Contact Backup: Name: Pravesh Gadjradj, MD; Phone Number: (212) 821-0850; Email: psg4001@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • New York Presbytarian Hospital
      • Contact: Pravesh S Gadjradj, MD; Phone Number: 212-821-0850; Email: psg4001@med.cornell.edu
      • Contact: Brendan Mendary, BS; Phone Number: (212) 821-0850; Email: brm4011@med.cornell.edu
      • Principal Investigator: Larry Bonassar, Prof.dr.
      • Principal Investigator: Roger Hartl, Prof.dr.
      • Sub-Investigator: Sertac Kernaz, MD
      • Sub-Investigator: Rachel Yerden, BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Numeric Rating for Back pain at 12 months	0 to 10 NRS	Baseline, 3 months, 6 months, 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Disc Height Index	MRI measurement	Baseline and 12 months or longer folllow-up after surgery
Pfirrman grading	MRI measurement	Baseline and 12 months or longer folllow-up after surgery
Change in NRS Leg pain	0 to 10 NRS	Baseline, 3 months, 6 months, 12 months after surgery
Complications	Infections, reoperations, blood loss.	Continrous monitoring during study during one year after surgery

Collaborators and Investigators

• Sponsor: New York Presbyterian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Sciatica; Discectomy; Lumbar Disc Herniation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: NYP19-04020103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No