이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

한 수준의 증상성 경도 내지 중등도 요추 퇴행성 디스크 질환 환자에서 IDCT(추간판 내 세포 치료)의 효과를 평가하는 연구 (IDCT)

2026년 10월 14일 업데이트: DiscGenics, Inc.

단일 수준, 증상성 경도 내지 중등도 요추 추간판 퇴행성 질환을 가진 대상자에서 IDCT의 안전성과 유효성을 평가하기 위한 전향적, 무작위, 이중 맹검, 가짜 대조군, 다기관 임상 연구

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)

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

162

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: IDCT (n=108); Intradiscal injection of IDCT in a single target disc

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

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

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

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Visual Analogue Scale (VAS) for low back pain
기간: 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)
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Visual Analogue Scale (VAS)
기간: 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)
기간: 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
기간: 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
기간: Day 1 to Week 104

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

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

기타 결과 측정

결과 측정
측정값 설명
기간
MRI Based evaluations
기간: 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
기간: Screening through Week 104

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

DiscGenics, Inc.

수사관

  • 연구 책임자: Lisa Flood, DiscGenics, Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 12월 23일

기본 완료 (추정된)

2027년 11월 24일

연구 완료 (추정된)

2028년 11월 24일

연구 등록 날짜

최초 제출

2025년 11월 17일

QC 기준을 충족하는 최초 제출

2025년 11월 20일

처음 게시됨 (실제)

2025년 11월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 14일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DGX-A02

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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