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Studie k vyhodnocení účinnosti intradiskální buněčné terapie (IDCT) u pacientů s jednostupňovým symptomatickým mírným až středně závažným degenerativním onemocněním bederních meziobratlových plotének (IDCT)

14. října 2026 aktualizováno: DiscGenics, Inc.

Prospektivní, randomizovaná, dvojitě zaslepená, placebem kontrolovaná, multicentrická studie hodnotící bezpečnost a účinnost IDCT u pacientů s jednostupňovou, symptomatickou mírnou až střední degenerací bederní meziobratlové ploténky

This is a Phase III, randomized, double-blinded, Sham-controlled, multi-center study in subjects with single-level, symptomatic lumbar (L3- S1) intervertebral disc degeneration. The study will have a 52-week primary period followed by 52 week Follow-up Period (total of 104 weeks).

The study protocol will be approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), and the study will be conducted in accordance with Good Clinical Practice (GCP). All subjects will provide written informed consent prior to Screening.

Approximately 162 subjects will be enrolled in the study. Up to 45 days prior to treatment, subjects will be screened for study inclusion, which includes obtaining baseline MRI and X-ray imaging. Imaging results for subjects initially eligible for study participation will be sent to a central imaging vendor for review and confirmation of eligibility, including the number of levels with degeneration. Subjects meeting all inclusion/exclusion criteria will be assigned to the corresponding treatment arm group and subsequently randomized to IDCT or Sham.

Randomization will occur approximately 7 to 14 days prior to the scheduled treatment administration date.

Overall, 162 subjects will be enrolled and randomized to IDCT or Sham in a 2:1 ratio.

  • IDCT (n=108)
  • Sham (n=54)

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

Adult subjects with a diagnosis of single-level, mild to moderate, symptomatic lumbar (L3-S1) intervertebral disc degeneration that give consent and meet all the inclusion criteria and none of the exclusion criteria will be enrolled in this study. The disease, single-level disc will be known as the 'target disc' and will be either L3/L4, L4/L5, or L5/S1.

Typ studie

Intervenční

Zápis (Odhadovaný)

162

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Alabama
      • Birmingham, Alabama, Spojené státy, 35235
        • Nábor
        • Alabama Clinical Therapeutics
        • Vrchní vyšetřovatel:
          • Brad 205-833-2228, MD
        • Kontakt:
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85054
        • Nábor
        • Mayo Clinic (AZ)
        • Vrchní vyšetřovatel:
          • John Freeman, MD
        • Kontakt:
      • Scottsdale, Arizona, Spojené státy, 85251
        • Nábor
        • HonorHealth
        • Vrchní vyšetřovatel:
          • Luis Tumialan, MD
        • Kontakt:
    • Arkansas
      • Little Rock, Arkansas, Spojené státy, 72205
        • Nábor
        • University of Arkansas for Medical Sciences
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Erica Petersen, MD
    • California
      • San Diego, California, Spojené státy, 92111
        • Nábor
        • Solaris Research Institute
        • Vrchní vyšetřovatel:
          • Krishnan Chakravarthy, MD
        • Kontakt:
      • Santa Monica, California, Spojené státy, 90403
        • Nábor
        • Source Healthcare
        • Vrchní vyšetřovatel:
          • Timothy Davis, MD
        • Kontakt:
      • Thousand Oaks, California, Spojené státy, 91320
        • Nábor
        • Pain Management and Injury Relief
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Alexander Hersel, MD
    • District of Columbia
      • Washington D.C., District of Columbia, Spojené státy, 20006
        • Nábor
        • International Spine, Pain and Performance Center
        • Vrchní vyšetřovatel:
          • Mehul Desai, MD
        • Kontakt:
    • Florida
      • Jacksonville, Florida, Spojené státy, 32224
        • Nábor
        • Mayo Clinic (FL)
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Wenchun Qu, MD
      • Miami, Florida, Spojené státy, 33136
        • Nábor
        • University of Miami Health System
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Barth Green, MD
      • Orlando, Florida, Spojené státy, 32832
      • St. Petersburg, Florida, Spojené státy, 33709
        • Nábor
        • Vantage Clinical Trials
        • Vrchní vyšetřovatel:
          • Robert Guirguis, MD
        • Kontakt:
      • Tampa, Florida, Spojené státy, 33709
        • Nábor
        • Vantage Clinical Trials
        • Vrchní vyšetřovatel:
          • Jorge Leal, MD
        • Kontakt:
    • Idaho
      • Boise, Idaho, Spojené státy, 83709
        • Ukončeno
        • Injury Care Family Care Research
      • Post Falls, Idaho, Spojené státy, 83854
    • Illinois
      • Chicago, Illinois, Spojené státy, 60612
        • Nábor
        • Rush University Medical Center
        • Vrchní vyšetřovatel:
          • John O'Toole, MD
        • Kontakt:
    • Indiana
      • Carmel, Indiana, Spojené státy, 46032
        • Nábor
        • Indiana Spine Group
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Kevin Macadaeg, MD
    • Kentucky
      • Louisville, Kentucky, Spojené státy, 40202
        • Nábor
        • Norton Leatherman Spine Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Steven Glassman, MD
    • Louisiana
      • New Orleans, Louisiana, Spojené státy, 70121
        • Nábor
        • Ochsner Health System
        • Vrchní vyšetřovatel:
          • Maged Guirguis, MD
        • Kontakt:
    • Minnesota
      • Rochester, Minnesota, Spojené státy, 55905
        • Nábor
        • Mayo Clinic (MN)
        • Vrchní vyšetřovatel:
          • Ryan D'Souza, MD
        • Kontakt:
    • Missouri
      • St Louis, Missouri, Spojené státy, 63141
        • Nábor
        • The Orthopedic Center of St. Louis
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Matthew Gornet, MD
    • New York
      • New York, New York, Spojené státy, 10022
        • Nábor
        • Weill Cornell Medicine for Comprehensive Spine Care
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Prabhav Deo, MD
    • North Carolina
      • Wilmington, North Carolina, Spojené státy, 28403
        • Nábor
        • Wake Research
        • Vrchní vyšetřovatel:
          • Jeremy Hoff, MD
        • Kontakt:
      • Winston-Salem, North Carolina, Spojené státy, 27103
        • Nábor
        • Carolinas Pain Institute/ Center For Clinical Research
        • Vrchní vyšetřovatel:
          • Christopher Gilmore, MD
        • Kontakt:
    • Ohio
      • Cleveland, Ohio, Spojené státy, 10524
        • Nábor
        • Cleveland Clinic
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Jijun Xu, MD
    • Oregon
      • Eugene, Oregon, Spojené státy, 97404
        • Nábor
        • Pacific Sports and Spine
        • Vrchní vyšetřovatel:
          • Gregory Moore, MD
        • Kontakt:
    • Pennsylvania
      • King of Prussia, Pennsylvania, Spojené státy, 19406
        • Nábor
        • Main Line Spine
        • Vrchní vyšetřovatel:
          • Scott Davidoff, MD
        • Kontakt:
    • Tennessee
      • Memphis, Tennessee, Spojené státy, 38120
    • Texas
      • Austin, Texas, Spojené státy, 78745
        • Nábor
        • Pain Specialists of America
        • Vrchní vyšetřovatel:
          • Genaro Gutierrez, MD
        • Kontakt:
    • Utah
      • Salt Lake City, Utah, Spojené státy, 84108
        • Nábor
        • University of Utah
        • Vrchní vyšetřovatel:
          • Zachary McCormick, MD
        • Kontakt:
    • Virginia
      • Richmond, Virginia, Spojené státy, 23238
        • Nábor
        • Virginia iSpine Physicians
        • Vrchní vyšetřovatel:
          • Michael DePalma, MD
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  1. Has a diagnosis of mild to moderate, symptomatic, single-level degenerative disc disease (DDD) from L3-S1.

  2. Has a target disc that meets Modified Pfirrmann Grade 3-7, as determined by a central radiologist.

  3. Is ≥18 and ≤75 years of age, skeletally mature, and has a body mass index (BMI) ≥18 kg/m2 and ≤38 kg/m2 at Screening.

  4. Has been experiencing chronic low back pain for at least 6 months prior to Screening.

  5. Has had low back pain that is unresponsive to at least 3 months of conservative care (nonoperative treatment) to include at least one non-pharmacological intervention which may include physical therapy, acupuncture, chiropractic manipulation, massage, and at home medically supervised exercise program and two pharmacological interventions which may include NSAIDs, acetaminophen, duloxetine, and/or injectable therapy.

  6. Has pre-treatment low back pain score of 45 to 90 on VAS (Visual Analogue Scale) for low back pain at Screening and Day 1.

  7. Has pre-treatment ODI score of 35 to 90 at Screening and Day 1.

  8. Is willing to voluntarily sign the informed consent form and agrees to the release of previous medical history for purposes of this study (i.e., HIPAA authorization) at Screening.

  9. Is physically and mentally able to comply with the protocol, able to understand and complete the required forms, and willing and able to adhere to the requirements of the protocol in the opinion of the Investigator.

  10. Female-born subjects of childbearing potential must agree to and comply with using highly effective methods of birth control for the duration of the study (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, condoms, or a vasectomized partner).-

    Exclusion Criteria:

    Physical/ Medical History Exclusion Criteria

  11. Has low back pain that in the Investigator's opinion is predominately myofascial in nature.

  12. Has constant, unchanging low back pain that is not improved in any spinal position.

  13. Has radiculopathy resulting from nerve compression.

  14. Has non-radicular unilateral or bilateral leg pain with intensity greater than 50% of the intensity of the low-back pain, as measured by VAS.

  15. Leg pain that is of radicular origin, i.e., due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces.

  16. Has frequent leg pain that extends below the knee.

  17. Has severe unilateral or bilateral osteoarthritis of the knee or hip.

  18. Severe spinal arthritis

  19. Has cauda equina syndrome.

  20. Has had previous lumbar spine surgery.

  21. Has had previous disc invasive treatment procedures (i.e., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation) or intradiscal injections (i.e., injection of corticosteroids, methylene blue, dextrose, or glucosamine and chondroitin sulfate) or diagnostic discography at L3-S1 within the 3 months prior to Screening.

  22. Subjects who have had basivertebral nerve ablation at L3-S1.

  23. Has clinical suspicion of facet pain as the primary pain generator.

  24. Has current infection at the planned procedure site, active systemic infection, or current or prior history of lumbar spinal infection (i.e., discitis, septic arthritis, epidural abscess).

  25. Has a history of fibromyalgia.

  26. Has tested positive for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human Immunodeficiency Virus (HIV).

  27. Has presence of an active malignancy or tumor, or a prior history of malignancy within the last five years (except for basal cell carcinoma of the skin).

  28. Has presence or prior history of a spinal malignancy.

  29. Has significant systemic disease, such as unstable angina or autoimmune disease, such as rheumatoid arthritis. Has a history of congenital or acquired coagulopathy or thrombocytopenia.

31. Is currently taking anticoagulant, antiplatelet, or thrombolytic medications (except for aspirin or nonsteroidal anti-inflammatory drugs [NSAIDS]) and at the Investigator's medical discernment and discretion is unable to withhold medications for the time required per site standard or care, prior to the IDCT injection or is taking antineoplastic medications.

32. Is at higher risk for post-surgical infection (e.g., taking immunosuppressants), has a severe infection or a history of serious infection.

33. Has concomitant conditions requiring daily oral steroid usage for more than 30 days in the preceding 90 days before Screening.

34. Is taking opioids greater than 20 MME per day on an intermittent (as needed) basis OR is taking 20 MME or greater daily for more than 3 months prior to Screening

35. Has a history of unexplained, easy, or persistent bruising or bleeding, bleeding from the gums, or bleeding problems experienced in previous surgical procedures.

36. Has a history of hypersensitivity or anaphylactic reaction to bovine products, sodium hyaluronate/ hyaluronan/ hyaluronic acid, gentamicin, amphotericin b, dimethyl sulfoxide (DMSO), crustaceous/ shellfish, or porcine products.

37. Has an uncontrolled psychiatric condition or substance/alcohol abuse that would potentially interfere with the subject's participation in the study within 2 years prior to Screening in the opinion of the Investigator.

38. Has positive serum pregnancy test or nursing at time of Screening or has plans to become pregnant within the planned length of the study (2 years).

39. Has a body habitus that precludes adequate fluoroscopic visualization for the procedure or the procedure is physically impossible.

40. Has or requires an implantable electronic defibrillator, pacemaker, or has other contraindication to MRI scanning or cannot tolerate MRI scanning. Subjects who are expected to require a defibrillator or pacemaker, as determined by the Investigator should be excluded.

41. Has participated in another clinical study within the 6 months prior to Screening.

42. Has been a recipient or plans to be a recipient during trial participation of stem cell product to treat the lumbar spine.

43. Has participated in a prior IDCT clinical study.

44. Has pending litigation against a health care professional, except where required by the insurer as a condition of coverage.

45. A person who would not be available for the entire planned length of the trial.

46. Has active or pending worker's compensation claims. 47. In the Investigators opinion, the subject is not suitable for participation in the clinical trial.

Imaging Exclusion Criteria:

48. Three discs (L3-S1) that have a Modified Pfirrmann Grade 4-7.

49. Has evidence of prior lumbar vertebral body fracture at L3-S1.

50. Has scoliosis with curvature > 10 degrees.

51. Has congenital spinal irregularities such as segmentation.

52. Has an acute fracture of the spine at the time of enrollment in the study. Clinically compromised vertebral bodies within L3-S1 due to current or past trauma, e.g., sustained pathological fracture or multiple fractures of vertebrae.

53. Has evidence of dynamic instability on lumbar flexion extension per screening radiographs as indicated by >4.5 mm of translational motion at L3-S1; >15° of angular motion at L3/-L4; >20° of angular motion at L4-L/5; or >25° angular motion at L5/-S1.

54. Has Grade 2 or higher spondylolisthesis at L3-S1, as assessed by Meyerding classification.

55. Has lumbar spondylitis or other undifferentiated spondyloarthropathy.

56. Has Modic Type III Changes at L3-S1.

57. Has radiographic evidence or suspicion of a full thickness annular tear at L3-S1.

58. Has evidence of abnormal disc morphology defined as an extrusion or sequestration according to Fardon classification at L3- S1.

59. Has herniation > 3 mm in AP dimension that is associated with nerve root compression.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: IDCT (n=108); Intradiscal injection of IDCT in a single target disc

1 mL intradiscal injection of 9,000,000 cells/mL
Biologický: IDCT (rebonuputemcel)

Single intradiscal injection of 1 mL of 9,000,000 cells/mL IDCT in a single target disc.
Falešný srovnávač: Sham (n=54);

Needle insertion up to the annulus of a single target disc.
Jiný: Sham (No Treatment)

Single Sham needle insertion up to the annulus of a single target disc.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Visual Analogue Scale (VAS) for low back pain
Časové okno: Week 52

VAS is a sliding visual scale of 0 being "no pain" and 100 being "worst pain Imaginable' to assess changesfrom baseline in low back pain compared to Sham
Week 52
Oswestry Disability Index (ODI)
Časové okno: Week 52

ODI is a 10-item questionnaire used to measure functional disability in people with low back pain. It is a self-administered tool that assesses how back pain affects daily activities like walking, sleeping, and personal hygiene, with scores ranging from 0% (no disability) to 100% (maximum disability).
Week 52
Adverse Events
Časové okno: Day 1 to Week 52 in each treatment group.

Incidence of grade 2 (moderate) or greater AEs and SAEs
Day 1 to Week 52 in each treatment group.
Adverse events of special interest
Časové okno: Day 1 to Week 52 in each treatment group

Incidence of Adverse Events of Special Interest (AESI) to include any symptomatic injury of the target disc including annular tear, disc herniation/extrusion/prolapse as well as discitis.
Day 1 to Week 52 in each treatment group

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Visual Analogue Scale (VAS)
Časové okno: Week 4, 12 and 26, 78 and 104

VAS is a sliding visual scale of 0 being "no pain" and 100 being "worst pain Imaginable' to assess changes from baseline in low back pain
Week 4, 12 and 26, 78 and 104
Oswestry Disability Index (ODI)
Časové okno: Week 4, 12 and 26, 78 and 105

ODI is a 10-item questionnaire used to measure functional disability in people with low back pain. It is a self-administered tool that assesses how back pain affects daily activities like walking, sleeping, and personal hygiene, with scores ranging from 0% (no disability) to 100% (maximum disability).
Week 4, 12 and 26, 78 and 105
EQ-5D
Časové okno: Enrollment through Week 104

EQ-5D is a validated too consisting of a set of questions covering five dimensions, with each dimension having a different severity level.

  1. Mobility: Ranging from "no problems walking about" to "confined to bed". Self-care: Ranging from "no problems with self-care" to "unable to wash or dress myself".
  2. Usual activities: Ranging from "no problems doing my usual activities" to "unable to do my usual activities" (e.g., work, study, housework).
  3. Pain/discomfort: Ranging from "no pain or discomfort" to "extreme pain or discomfort".
  4. Anxiety/depression: Ranging from "not anxious or depressed" to "extremely anxious or depressed".
  5. Visual Analog Scale (EQ VAS): A scale (typically 0-100) where respondents mark their overall health from "worst imaginable" to "best imaginable".
Enrollment through Week 104
Disc Volume
Časové okno: Day 1 to Week 104

MRI assessment of Disc Volume though Week 104
Day 1 to Week 104
Pain Medication Use
Časové okno: Enrollment to Week 104

Concomitant pain medication use for low back pain related to the target disc
Enrollment to Week 104
Concomitant Therapy
Časové okno: Enrollment to Week 104

Concomitant medical therapy for low back pain (physical therapy, acupuncture, chiropractic manipulation, massage, and at-home, medically supervised exercise program etc.) use for low back pain
Enrollment to Week 104
Treatment Failure Rate
Časové okno: Enrollment to week 104

Treatment failure rate (defined as an invasive non-surgical or surgical intervention) directly related to the target disc.
Enrollment to week 104
Adverse Events
Časové okno: Enrollment to Week 104

The incidence of grade 2 (moderate) or greater AEs and SAEs
Enrollment to Week 104
Adverse Events of Special Interest (AESI)
Časové okno: Enrollment to Week 104

The incidence of Adverse Events of Special Interest (AESI) observed defined as any one of the followings symptomatic injury of the target disc including annular tear, disc, herniation/extrusion/prolapse or any case of discitis.
Enrollment to Week 104

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
MRI Based evaluations
Časové okno: Enrollment through Week 104

MRI Evaluation of the lumbar spine will be reported as an aggregate in one report to assess of disc height, Modified Pfirrmann grade, Modic changes, annular tears/fissures, endplate integrity, herniation, and any additional noteworthy observations at 12, 26, 52, 78, and 104.
Enrollment through Week 104
X-ray evaluation of the lumbar spine
Časové okno: Screening through Week 104

X-ray evaluation of flexion/extension will be assessed and measure in degrees of angles.
Screening through Week 104

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

DiscGenics, Inc.

Vyšetřovatelé

  • Ředitel studie: Lisa Flood, DiscGenics, Inc.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

23. prosince 2025

Primární dokončení (Odhadovaný)

24. listopadu 2027

Dokončení studie (Odhadovaný)

24. listopadu 2028

Termíny zápisu do studia

První předloženo

17. listopadu 2025

První předloženo, které splnilo kritéria kontroly kvality

20. listopadu 2025

První zveřejněno (Aktuální)

28. listopadu 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. října 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. října 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

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  • DGX-A02

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Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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