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Trial record 2 of 6 for:    InGeneron

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

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ClinicalTrials.gov Identifier: NCT03513731
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : September 7, 2018
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 Thoracic 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

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
Estimated Study Start Date : August 31, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : April 1, 2020

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 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female from 18 to 65 years of age
  2. Documented diagnosis of chronic facet joint osteoarthritis
  3. The ability of subjects to give appropriate consent or have a legally authorized representative available.

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. Obesity > 40 BMI
  4. Subjects who have undergone disc fusions
  5. Osteopenia, osteoporosis risk estimation Score >6
  6. Any lumbar intradiscal injection at the symptomatic or adjacent discs 3 months prior to treatment
  7. epidural injections within 8 weeks prior to treatment
  8. Received chronic treatment with systemic corticosteroids within 14 days of injection procedure
  9. Evidence of malignant disorder/neoplasm in past 24 months
  10. treatment with investigational device within 6 months
  11. prior stem cell/allogenic stem treatment at the target intervertebral disc
  12. An average baseline morphine equivalent dose >40 mg/day
  13. High risk for bleeding or infection
  14. Current infection or priory history of spinal infection at the symptomatic level
  15. Severe and/or chronic pain conditions (defined as pain that persists >6 months) that confound symptom assessment
  16. any medical condition that would preclude participation in the study in the opinion of the investigators
  17. cauda equina syndrome
  18. ongoing workman compensation litigation
  19. Currently incarcerated (prisoners)
  20. drug or alcohol abuse within 364 days
  21. Inability to complete all required diary entries
  22. psychiatric disorder that prevent participation in the opinion of the investigators
  23. body habitus precluding fluoroscopic visualization
  24. Failed any component of the lumbar neurologic exam baseline
  25. A positive screen for human immunodeficiency virus (HIV) by antibodies or nucleic acid test
  26. Clinically significant nerve pain (e.g. chronic radiculopathy)
  27. Sacroiliac joint syndrome
  28. compressive pathology (e.g. Stenosis, disc herniation >3 mm)
  29. Intact disc bulge/protrusion at the symptomatic disc > 3mm
  30. lumbar intervertebral foraminal stenosis
  31. Symptomatic central vertebral canal or lateral recess stenosis
  32. Spondylolisthesis, severe instability spondylolysis.
  33. Severe instability that require surgical intervention
  34. Acute Vertebral fracture
  35. History of tobacco and nicotine usage
  36. Insufficient amount of subcutaneous tissue to allow recovery of at least 100 ml of lipoaspirate
  37. Subjects who have document allergy to radiographic agents.
  38. Subjects that demonstrate <80% relief of their pain after diagnostic injection.

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


Locations
United States, South Dakota
Sanford Physical Medicine & Rehabilitation Clinic and Sanford Spine Center Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Amanda Mensing    605-312-6444    Amanda.mensing@SanfordHealth.org   
Contact: Central Referral Line    877-878-4825      
Sponsors and Collaborators
InGeneron, Inc.
Sanford Health
Investigators
Principal Investigator: Thomas Boetel, MD Sanford Health

Publications:
Responsible Party: InGeneron, Inc.
ClinicalTrials.gov Identifier: NCT03513731     History of Changes
Other Study ID Numbers: OAFJ-001
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases