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Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03513731
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : August 27, 2020
Sponsor:
Collaborator:
Sanford Health
Information provided by (Responsible Party):
InGeneron, Inc.

Brief Summary:
This is a prospective, randomized, active controlled, single site safety and efficacy study in subjects suffering from chronic lumber back pain due to facet joint osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the facet joint.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Facet Joint of Lumbar Spine Device: Adipose-derived stem cell injection Drug: Corticosteroid injection Not Applicable

Detailed Description:
Patients will fall into two categories: treatment group (20 subjects) and non-treatment or control group (20 subjects). The treatment group will undergo a small liposuction procedure and receive facet joint osteoarthritis treatment with an ultrasound-guided injection of 5 ml adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5 ml corticosteroid injection into the point of injury

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: It is a single-blinded trial in which the radiologists are blinded. Subjects and the Investigator are unblinded.
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Injection of Adipose-derived Regenerative Cells (ADRCs) in Patients Suffering From Osteoarthritis of the Facet Joints
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Adipose-derived stem cell injection
ADRC treatment group will receive ADRCs yielded from processing of lipoaspirate by a fluoroscopic-guided injection into the affected segment. The segment will consist of 2 joints per level and up to two levels (no more than 4 joints) injected during the procedure.
Device: Adipose-derived stem cell injection
ADRC injection into the facet joint
Other Name: ADRCs

Active Comparator: Corticosteroid injection
The control group will undergo standard fluoroscopy guided injection of glucocorticoids and local anesthetics.
Drug: Corticosteroid injection
Corticosteroid injection into the facet joint
Other Name: steroid injection




Primary Outcome Measures :
  1. Safety - Incidence of Treatment-Emergent Adverse Events experimental group [ Time Frame: 52 weeks ]
    Subjects will be monitored for adverse events


Secondary Outcome Measures :
  1. Efficacy - Change in Pain Scores on the VAS Scale at All Follow-up Visits [ Time Frame: 6, 12, 26, 52 weeks ]
    Patient outcomes for pain will be recorded (line from 0: no pain to 100:worst pain)

  2. Efficacy - Change in Function Scores on the EQ-5D at All Follow-up Visits [ Time Frame: 6, 12, 26, and 52 weeks ]
    Patient outcomes for function will be recorded

  3. Efficacy - Change in Function Scores on the Oswestry Disability Index at All Follow-up Visits [ Time Frame: 6, 12, 26, and 52 weeks ]
    Patient outcomes for function will be recorded. (ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100% (may be bed bound or exaggerating their symptoms).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects, between 18 and 75 years of age.
  2. Have documented the diagnosis of facet joint osteoarthritis from L1 to S1 in the opinion of the investigator.
  3. Have a documented diagnosis of symptomatic facet joint syndrome is defined as the following (subject must meet all the listed conditions):

    1. Chronic low back pain for at least 6 months.
    2. Have failed 3 months of conservative back pain care. (Conservative treatment regimens may include any or all of the following: initial rest, medications [e.g., anti-inflammatory, analgesics, narcotics/opioids, muscle relaxants], massage, acupuncture, chiropractic manipulations, activity modification, home-directed lumbar exercise program, and non- invasive pain control treatments or procedures).
    3. Have undergone supervised physical therapy, such as daily walking routines, therapeutic exercises, and back education programs specifically for the treatment of low back pain.
    4. Change from normal spine morphology at the symptomatic level as defined by Radiographic evaluation for Lumbar facet joint osteoarthritis.
    5. The baseline pain score of at least 4 on a pain scale of 0-10, over 24 hours
  4. Subjects demonstrate >80% relief of their pain after diagnostic injection.
  5. Signed informed consent indicating the subject is willing to undergo treatment and willing to be available for each examination scheduled over the study duration

Exclusion Criteria:

  1. Female subjects who are pregnant or nursing, or women planning to become pregnant within 12 months following treatment.
  2. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least one months prior to study entry.
  3. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI > 40)
  4. Any lumbar intradiscal injection, including steroids, at the symptomatic or adjacent discs less than 3 months prior to treatment injection, except for the following injections performed at least 2 weeks prior to study treatment:

    1. Contrast medium (discography or other diagnostic injection)
    2. NSAIDs
    3. Nerve-blocking anesthetics (e.g., lidocaine, bupivacaine)
    4. Antibiotics
    5. Saline
  5. Epidural steroid injections, prior lumbar facet joint injection, medial branch block or radiofrequency ablation of facet joint nerves within 8 weeks prior to treatment injection.
  6. Have received chronic (more than 7 consecutive days) treatment with systemic corticosteroids at a dose equivalent to prednisone ≥ 10 mg/day within 14 days prior to an injection procedure.
  7. Active malignancy or tumor as a source of symptoms or history of malignancy within the 2 years prior to enrollment on the study, except history of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or squamous cell carcinoma of the cervix if fully excised and with clear margins.
  8. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  9. Have been a recipient of prior allogeneic stem cell/progenitor cell therapy for any indication or autologous stem cell/progenitor cell therapy or other biological intervention to repair the target intervertebral disc or facet joint.
  10. An average baseline morphine equivalent dose (MED) of >40mg/day collected during the screening visit.
  11. Are at a higher risk, in the opinion of the investigator, for bleeding (e.g., bleeding disorder, or taking anticoagulants, except low dose aspirin) or infection (e.g., taking immunosuppressants, have a severe infection, or a history of serious infection).
  12. Current infection or prior history of spinal infection at the symptomatic level (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
  13. Severe and/or chronic pain conditions that may potentially confound facet joint symptom assessment, in the opinion of the investigator.
  14. Cauda equina syndrome.
  15. Receiving workman's compensation unless litigation is complete.
  16. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
  17. Subjects with documented history of alcohol or drug abuse within the last year.
  18. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of patient reported outcome instruments.
  19. Body habitus precluding adequate fluoroscopic visualization for the procedure or the procedure is physically impossible due to inability to inject the facet joint.
  20. Failed any component of the lumbar neurological exam at baseline (i.e., motor, sensory, or a reflex portion of the exam).
  21. The subject is receiving immunosuppressant therapy or has a known immunologic or severe autoimmune disease that requires chronic immunosuppressive or immunomodulatory therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, etc.).
  22. Clinically significant, in the opinion of the investigator, nerve pain (e.g., chronic radiculopathy) or clinically significant sacroiliac joint pain based on targeted, pre-specified physical examination, and, if deemed medically necessary, confirmed by anesthetic injection. If a previously performed anesthetic injection to confirm SI joint pain was performed up to 6 months prior to injection (with documentation indicating no SI joint pain), this does not need to be repeated at screening.
  23. Symptomatic lumbar intervertebral foraminal stenosis at the symptomatic level resulting in clinically significant spinal nerve root compression, in the opinion of the investigator.
  24. Symptomatic central vertebral canal, lateral recess stenosis or foraminal stenosis, in the opinion of the investigator.
  25. Severe instability where, in the opinion of the investigator, surgical interventions to stabilize the segment would be required.
  26. An acute fracture of the spine. Clinically compromised, in the opinion of the investigator, vertebral bodies at the symptomatic level due to current or past trauma, e.g., sustained a pathological fracture or multiple fractures of vertebrae.
  27. History of Chronic tobacco and nicotine usage.
  28. Insufficient amount of subcutaneous tissue to allow recovery of at least 100 mL of adipose tissue.
  29. Subjects who have document allergy to radiographic agents or sodium citrate or any "caine" type of local anesthetic.
  30. Subjects with radicular leg pain as determined by investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513731


Contacts
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Contact: Hayden Pastorini (713) 440 9900 ext 126 HPastorini@ingeneron.com
Contact: Glenn Winnier (713) 440 9900 gwinnier@ingeneron.com

Locations
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United States, Florida
Sports and Orthopedic Center Recruiting
Coral Springs, Florida, United States, 33067
Contact: Nilay Mehta, MD    954-204-0052    nilaymehta@pioneerclinical.com   
United States, South Dakota
Sanford Physical Medicine & Rehabilitation Clinic and Sanford Spine Center Active, not recruiting
Sioux Falls, South Dakota, United States, 57104
Sponsors and Collaborators
InGeneron, Inc.
Sanford Health
Investigators
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Principal Investigator: Thomas Boetel, MD Sanford Health
Publications:
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Responsible Party: InGeneron, Inc.
ClinicalTrials.gov Identifier: NCT03513731    
Other Study ID Numbers: OAFJ-001
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases