Recruiting

Autologous Bone Marrow Aspirate

Sponsor:

New York Presbyterian Hospital

Code:

NCT05146583

Conditions

Lumbar Disc Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Autologous bone marrow aspirate injected intradiscal after microdiscectomy

Discectomy only

Study Details

Brief summary:

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

Conditions

Lumbar Disc Disease

Study ID

NCT05146583

Start date

Nov 1, 2021

Status verified date

Dec, 2021

Completion date

Jun 1, 2023

Anticipated

Primary completion date

Jun 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Interventions

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).

Primary outcome measure

  • Change in Numeric Rating for Back pain at 12 months [ Time Frame: Baseline, 3 months, 6 months, 12 months after surgery ]

Central Contacts and Locations

Central contacts

Roger Hartl, Prof.dr.

(212) 821-0850ermabell@cornell.edu.com

Pravesh Gadjradj, MD

(212) 821-0850psg4001@med.cornell.edu

Locations

New York Presbytarian Hospital

Recruiting

New York, New York, United States, 10021

Contacts

Pravesh S Gadjradj, MD

212-821-0850psg4001@med.cornell.edu

Brendan Mendary, BS

(212) 821-0850brm4011@med.cornell.edu

Principal Investigator:

Larry Bonassar, Prof.dr.

More Information

Sponsor

New York Presbyterian Hospital

Last update posted

Dec 21, 2021

Last verified

Dec, 2021

Keywords

  • Sciatica
  • Lumbar Disc Herniation
  • Discectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Presbyterian Hospital on 2021-12-21.