--- title: A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo nct_id: NCT01771471 overall_status: TERMINATED phase: PHASE2 sponsor: ISTO Technologies, Inc. study_type: INTERVENTIONAL primary_condition: Degenerative Disc Disease countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01771471.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01771471" ct_last_update_post_date: 2017-08-31 last_seen_at: "2026-05-12T07:21:42.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo **Official Title:** A Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs With Allogeneic Cultured Chondrocytes **NCT ID:** [NCT01771471](https://clinicaltrials.gov/study/NCT01771471) ## Key Facts - **Status:** TERMINATED - **Why Stopped:** Change in clinical strategy - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 44 - **Lead Sponsor:** ISTO Technologies, Inc. - **Conditions:** Degenerative Disc Disease - **Start Date:** 2012-11 - **Completion Date:** 2020-09 - **CT.gov Last Update:** 2017-08-31 ## Brief Summary This is a clinical study to collect safety and preliminary efficiency information on the use of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain. ## Detailed Description This is a Phase II clinical study to collect additional safety data and preliminary efficiency of juvenile chondrocytes, delivered in fibrin carrier (NuQu®) to the nucleus of lumbar intervertebral discs for the treatment of discogenic pain. This to be accomplished through a double blinded, placebo-controlled study of clinically meaningful endpoints including validated, subject reported outcomes of pain and disability, health related quality of life and subject satisfaction with treatment. ## Eligibility - **Minimum age:** 21 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form; * Is at least 21 years of age; * Have central low back pain aggravated by movement and or postural changes (standing/sitting); * Have had back pain for at least 6 months, and have failed conservative management * One Grade III or IV (Pfirrmann Scale) degenerated lumbar disc; Exclusion Criteria: * Current disc extrusion at any level in their lumbar spine; disc bulges or protrusions at any level in the lumbar spine resulting in nerve root compression; * Severe disc narrowing (equal to or more than 50% loss of disc height at the targeted level); * Type II or III Modic changes at any level; * Type I Modic changes at any level other than the targeted level; * Type I Modic changes at the treated level if maximum height of the changes is 25% or more of the vertebral body height; * Osteoporotic compression fracture at any vertebral level; * Lumbar Scheurmann's disease; * Antero or retrolisthesis ≥ 3mm at any level; * Currently experiencing chronic pain generating from any other source, which (in the judgment of the investigator) may interfere with the evaluation of back pain, and or disability; * Infection at the planned treatment site, history of systemic or local infection, which (in the investigator's judgment) may compromise subject participation and/or safety; * Currently diagnosed with immune-deficiency, which in the investigator's opinion may compromise subject participation and/or safety; * Receiving any immune-suppressant therapies other than short term steroid preparations; * BMI≥40; * Diagnosed with any comorbid conditions including: abnormal bleeding, AIDS, diabetes, hepatic or renal disease, and cardiopulmonary disorders such as COPD, MI and CHF; active malignancy or history of malignancy, or diseases of bone metabolism, which in the investigator's opinion may compromise subject participation and/or safety; * Has a history of alcoholism, medication or intravenous drug abuse, psychosis, is a prisoner, has a personality disorder(s), poor motivation, emotional or intellectual issues that would likely make the subject unreliable for the study, or 3 or more Waddell Signs of nonorganic Behavior or any combination of variables in the Investigator's judgment that should exclude a potential subject; * Has pending litigation against a health care professional, except where required by the insurer as a condition of coverage, personal injury compensation or litigation claims; * Has active or pending workers' compensation claims; * Has contraindications for MRI. ``` ## Arms - **NuQu treatment** (EXPERIMENTAL) — single administration - **Saline** (OTHER) — single administration ## Interventions - **NuQu** (BIOLOGICAL) — Allogenic juvenile chondrocytes (NuQu) in fibrin carrier. - **Placebo** (OTHER) — 0.9% w/v Sodium Chloride for Injection, USP ## Primary Outcomes - **Oswestry Disability Index** _(time frame: 12 months)_ ## Secondary Outcomes - **Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition** _(time frame: 24 Months)_ - **MRI** _(time frame: 24 Months)_ - **Visual Analog Scale** _(time frame: 24 Months)_ ## Locations (10) - Alabama Orthopedic and Spine Center, Birmingham, Alabama, United States - California Spine Diagnostics, San Francisco, California, United States - The Spine Institute, Center for Spinal Restoration, Santa Monica, California, United States - Ortho Georgia, Macon, Georgia, United States - Tufts University School of Medicine, Newton, Massachusetts, United States - Weill Cornell Medical College, New York, New York, United States - Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina, United States - The NeuroSpine Institute, Eugene, Oregon, United States - Spine Team Texas, Southlake, Texas, United States - Spinal Reseach Foundation, Reston, Virginia, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.whyStopped` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.the neurospine institute|eugene|oregon|united states` — added _(2026-05-12)_ - `locations.spine team texas|southlake|texas|united states` — added _(2026-05-12)_ - `locations.spinal reseach foundation|reston|virginia|united states` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.alabama orthopedic and spine center|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.california spine diagnostics|san francisco|california|united states` — added _(2026-05-12)_ - `locations.the spine institute, center for spinal restoration|santa monica|california|united states` — added _(2026-05-12)_ - `locations.ortho georgia|macon|georgia|united states` — added _(2026-05-12)_ - `locations.tufts university school of medicine|newton|massachusetts|united states` — added _(2026-05-12)_ - `locations.weill cornell medical college|new york|new york|united states` — added _(2026-05-12)_ - `locations.carolina neurosurgery and spine associates|charlotte|north carolina|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01771471.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01771471* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*