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Safety and tolerability of intradiscal implantation of combined autologous adipose-derived mesenchymal stem cells and hyaluronic acid in patients with chronic discogenic low back pain: 1-year follow-up of a phase I study.

ABSTRACT: Adipose tissue-derived mesenchymal stem cells (AT-MSCs) offer potential as a therapeutic option for chronic discogenic low back pain (LBP) because of their immunomodulatory functions and capacity for cartilage differentiation. The goal of this study was to assess the safety and tolerability of a single intradiscal implantation of combined AT-MSCs and hyaluronic acid (HA) derivative in patients with chronic discogenic LBP.We performed a single-arm phase I clinical trial with a 12-month follow-up and enrolled 10 eligible chronic LBP patients. Chronic LBP had lasted for more than 3 months with a minimum intensity of 4/10 on a visual analogue scale (VAS) and disability level???30% on the Oswestry Disability Index (ODI). The 10 patients underwent a single intradiscal injection of combined HA derivative and AT-MSCs at a dose of 2?×?107 cells/disc (n?=?5) or 4?×?107 cells/disc (n?=?5). Safety and treatment outcomes were evaluated by assessing VAS, ODI, Short Form-36 (SF-36), and imaging (lumbar spine X-ray imaging and MRI) at regular intervals over 1 year.No patients were lost at any point during the 1-year clinical study. We observed no procedure or stem cell-related adverse events or serious adverse events during the 1-year follow-up period. VAS, ODI, and SF-36 scores significantly improved in both groups receiving both low (cases 2, 4, and 5) and high (cases 7, 8, and 9) cell doses, and did not differ significantly between the two groups. Among six patients who achieved significant improvement in VAS, ODI, and SF-36, three patients (cases 4, 8, and 9) were determined to have increased water content based on an increased apparent diffusion coefficient on diffusion MRI.Combined implantation of AT-MSCs and HA derivative in chronic discogenic LBP is safe and tolerable. However, the efficacy of combined AT-MSCs and HA should be investigated in a randomized controlled trial in a larger population.ClinicalTrials.gov NCT02338271 . Registered 7 January 2015.

SUBMITTER: Kumar H

PROVIDER: S-EPMC5688755 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Safety and tolerability of intradiscal implantation of combined autologous adipose-derived mesenchymal stem cells and hyaluronic acid in patients with chronic discogenic low back pain: 1-year follow-up of a phase I study.

Kumar Hemant H Ha Doo-Hoe DH Lee Eun-Jong EJ Park Jun Hee JH Shim Jeong Hyun JH Ahn Tae-Keun TK Kim Kyoung-Tae KT Ropper Alexander E AE Sohn Seil S Kim Chung-Hun CH Thakor Devang Kashyap DK Lee Soo-Hong SH Han In-Bo IB

Stem cell research & therapy 20171115 1

<h4>Background</h4>Adipose tissue-derived mesenchymal stem cells (AT-MSCs) offer potential as a therapeutic option for chronic discogenic low back pain (LBP) because of their immunomodulatory functions and capacity for cartilage differentiation. The goal of this study was to assess the safety and tolerability of a single intradiscal implantation of combined AT-MSCs and hyaluronic acid (HA) derivative in patients with chronic discogenic LBP.<h4>Methods</h4>We performed a single-arm phase I clinic ...[more]

PMID: 29141662

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Project description:IntroductionDiscogenic low back pain (DLBP) is a common disease, and its occurrence is closely related to intervertebral disc (IVD) degeneration. At present, none of the traditional treatment methods can repair the degenerated IVD. The emergence of stem cell therapy makes it possible to repair and regenerate IVD tissue, among which adipose derived mesenchymal stem cells (ADMSCs) transplantation therapy has become a hot spot of current research. Therefore, this trial aimed to investigate the safety and efficacy of using autologous cultured ADMSCs combined with hyaluronic acid (HA) hydrogel in the treatment of DLBP.Methods and analysisThis study is a randomised, dose-escalation, placebo-controlled, double-blind, single-centre, phase II clinical trial to evaluate the efficacy and safety of autologous cultured ADMSCs combined with HA hydrogel in the treatment of patients with DLBP. The 100 eligible patients will be randomly divided into three experimental groups with different doses and one placebo control group in a ratio of 1:1:1:1. All patients will undergo liposuction to obtain ADMSCs, followed by autologous cultured ADMSC mixtures or placebo transplantation after 3 weeks. The patients will be followed up to 24 months after the transplant. The primary end point of this trial is the Visual Analogue Scale. Secondary end points include the Oswestry Disability Index, Japanese Orthopaedic Association Scores, the Mos 36-item short form, the Modic classification, Pfirrmann grade, height and segment range of motion of the IVD, vital signs (temperature, pulse, respiration, blood pressure), blood routine, liver and kidney function, immunological examination, urinalysis and treatment emergent adverse events.Ethics and disseminationThe study protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Dalian Medical University and registered in the Chinese Clinical Trial Registry. Dissemination of the results will be presented at a conference and in peer-reviewed publications.Trial registration numberChiCTR2200058291.

Project description:BackgroundAutologous chondrocyte implantation (ACI) is an established method for treating cartilage defects in the knee of adult patients. However, less is known about its effectiveness in adolescents.HypothesisThird-generation matrix-associated ACI (MACI) using spheroids (co.don chondrosphere/Spherox) is an effective and safe treatment for articular cartilage defects in adolescents aged 15 to 17 years, with outcomes comparable with those for young adults aged 18 to 34 years.Study designCohort study; Level of evidence, 3.MethodsA total of 71 patients (29 adolescents, 42 young adults) who had undergone ACI using spheroids were evaluated retrospectively in this multicenter study. For adolescents, the mean defect size was 4.6 ± 2.4 cm2, and the follow-up range was 3.5 to 8.0 years (mean, 63.3 months). For young adults, the mean defect size was 4.7 ± 1.2 cm2, and the follow-up range was 3.8 to 4.3 years (mean, 48.4 months). At the follow-up assessment, outcomes were assessed by using validated questionnaires (Knee injury and Osteoarthritis Outcome Score [KOOS], International Knee Documentation Committee [IKDC] subjective knee evaluation form and current health assessment form, and modified Lysholm score), the magnetic resonance observation of cartilage repair tissue (MOCART) score, and if relevant, time to treatment failure. Safety was assessed by the treatment failure rate.ResultsNo significant difference between the 2 study groups was found for KOOS, IKDC, or MOCART scores, with all patients achieving high functional values. A significant difference was found in the modified Lysholm score, favoring the young adult group over the adolescent group (22.3 ± 1.9 vs 21.0 ± 2.4, respectively; P = .0123). There were no differences between the rates of treatment failure, with 3% in the adolescent group and 5% in the young adult group.ConclusionThird-generation MACI using spheroids is a safe and effective treatment for large cartilage defects of the knee in adolescents at midterm follow-up. Outcomes are comparable with those for young adults after ACI.

Dataset Information

Safety and tolerability of intradiscal implantation of combined autologous adipose-derived mesenchymal stem cells and hyaluronic acid in patients with chronic discogenic low back pain: 1-year follow-up of a phase I study.

Publications

Safety and tolerability of intradiscal implantation of combined autologous adipose-derived mesenchymal stem cells and hyaluronic acid in patients with chronic discogenic low back pain: 1-year follow-up of a phase I study.

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