NCT04559295

Brief Summary

Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_2 low-back-pain

Timeline
Completed

Started Nov 2018

Typical duration for phase_2 low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

August 31, 2020

Last Update Submit

September 21, 2020

Conditions

Low Back PainDisc DiseaseDisc DegenerationArthropathy VertebraeSacral DisorderRadiculopathySpinal Stenosis

Keywords

Stem cellsBone marrow concentrateDiscMinimally invasiveInjectionsFacet jointSacroiliac jointEpidural space

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index (ODI)

    The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst).

    Two Years

Secondary Outcomes (7)

  • Numeric Rating Scale (NRS)

    Two Years

  • Visual Analog Scale (VAS) for back pain

    Two Years

  • Visual Analog Scale (VAS) for leg pain

    Two Years

  • PROMIS Physical Health

    Two Years

  • PROMIS Mental Health

    Two Years

  • +2 more secondary outcomes

Study Arms (2)

Stem Cells (BMC)

EXPERIMENTAL

Subjects in the BMC arm received an injection of bone marrow concentrate

Biological: Bone Marrow Concentrate

Control

NO INTERVENTION

Subjects in the control arm received no treatment for their condition

Interventions

Bone Marrow ConcentrateBIOLOGICAL

The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints

Also known as: Stem Cells
Stem Cells (BMC)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without protrusions/herniations and facet/sacroiliac joint pain
  • Patients with mild to severe spinal stenosis
  • Patients with radiculopathy
  • Patients with disc extrusions
  • Patients with failed spinal fusion
  • Patients with mild to severe facet arthropathy
  • Patients with suspected sacroiliac joint disease
  • Age 18 to 60 years
  • Mild to severe loss of intervertebral disc height
  • Pain is not responsive to conservative treatment measures (oral medication, epidural steroid injections, physical therapy)
  • Pain persists for an extended period of time (i.e., at least 3 months)
  • High intensity zone (HIZ) in annular fissure or adjacent to annular fissure detected on T2 or STIR MRI
  • No evidence of contraindications to undergo procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer
  • English speaking

You may not qualify if:

  • Spinal Deformity (Scoliosis \>20 degrees, Spondylolisthesis)
  • Sequestered fragments, severe thecal sac compression
  • Severe neurologic deficit
  • Non-English speaking
  • Bone marrow disorders
  • Immunosuppressed Patients
  • Patients with coagulopathy
  • Localized infection in the area of skin penetration
  • Spinal infection
  • Serious medical co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem Cures

Cincinnati, Ohio, 45230, United States

Location

MeSH Terms

Conditions

Low Back PainIntervertebral Disc DegenerationRadiculopathySpinal Stenosis

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Sairam Atluri, MD

    Stem Cures

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Independent Observer was blinded as to wether a subject received treatment or was in the control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective evaluation of a cohort of patients with a specific characteristic over time to see if they develop a particular endpoint or outcome based on a stated hypothesis.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 22, 2020

Study Start

November 21, 2018

Primary Completion

March 19, 2020

Study Completion

April 30, 2021

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations

US(1)