title: Intra-discal injection of autologous, hypoxic cultured bone marrow-derived mesenchymal stem cells in five patients with chronic lower back pain: a long-term safety and feasibility study.
abstract: Chronic low back pain due to disc degeneration represents a major social and economic burden worldwide. The current standard of care is limited to symptomatic relief and no current approved therapy promotes disc regeneration. Bone marrow-derived mesenchymal stem cells (MSCs) are easily accessible and well characterized. These MSCs are multipotent and exhibit great tissue regenerative potential including bone, cartilage, and fibrous tissue regeneration. The use of this cell-based biologic for treating protruding disc herniation and/or intervertebral disc degeneration is a promising therapeutic strategy, due to their known regenerative, immuno-modulatory and anti-inflammatory properties.
  
  
  
  Five patients diagnosed with degenerative disc disease received an intra-discal injection of autologous, hypoxic cultured, bone marrow-derived mesenchymal stem cells (15.1-51.6 million cells) as part of a previous study. These patients were re-consented to participate in this study in order to assess long-term safety and feasibility of intra-discal injection of autologous, hypoxic cultured, bone marrow-derived mesenchymal stem cells 4-6 years post mesenchymal stem cell infusion. The follow-up study consisted of a physical examination, a low back MRI, and a quality of life questionnaire.
  
  
  
  Patients' lower back MRI showed absence of neoplasms or abnormalities surrounding the treated region. Based on the physical examination and the quality of life questionnaire, no adverse events were reported due to the procedure or to the stem cell treatment 4-6 years post autologous, hypoxic cultured mesenchymal stem cell infusion. All patients self-reported overall improvement, as well as improvement in strength, post stem cell treatment, and four out of five patients reported improvement in mobility.
  
  
  
  This early human clinical data suggests the safety and feasibility of the clinical use of hypoxic cultured bone marrow-derived mesenchymal stem cells for the treatment of lower back pain due to degenerative disc disorders and support further studies utilizing hypoxic cultured bone marrow-derived stem cells. The overall improvements reported are encouraging, but a larger double-blind, controlled, randomized clinical study with significant number of patients and implementation of validated endpoint measurements are next steps in order to demonstrate efficacy of this cell-based biologic.
authors: BioRestorative Therapies, Inc., 40 Marcus Drive, Suite One, Melville, NY, 11747, USA.
authors: Christian
authors: C
authors: Elabd
authors: The Centeno-Schultz Clinic, 403 Summit Boulevard, Unit 201, Broomfield, CO, 80021-8253, USA.
authors: Christopher J
authors: CJ
authors: Centeno
authors: The Centeno-Schultz Clinic, 403 Summit Boulevard, Unit 201, Broomfield, CO, 80021-8253, USA.
authors: John R
authors: JR
authors: Schultz
authors: Department of Physiatry, Hospital for Special Surgery, 429 E 75th Street, 3rd Floor, New York, NY, 10021, USA.
authors: Gregory
authors: G
authors: Lutz
authors: Institute for Molecular Medicine, Huntington Beach, CA, 92649, USA.
authors: Thomas
authors: T
authors: Ichim
authors: BioRestorative Therapies, Inc., 40 Marcus Drive, Suite One, Melville, NY, 11747, USA. fsilva@biorestorative.com.
authors: Francisco J
authors: FJ
authors: Silva
mesh_terms: D000328:Adult; D015687:Cell Hypoxia; D002478:Cells, Cultured; D059350:Chronic Pain / Q000628:therapy*; D004333:Drug Administration Routes; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007267:Injections; D007403:Intervertebral Disc / Q000473:pathology*; D017116:Low Back Pain / Q000628:therapy*; D008279:Magnetic Resonance Imaging; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects*; D059630:Mesenchymal Stem Cells / Q000166:cytology*; D008875:Middle Aged; D011795:Surveys and Questionnaires; D014182:Transplantation, Autologous; D055815:Young Adult
keywords: Autologous; Bone marrow; Cell therapy; Degenerative disc disease; Feasibility; Hypoxic; Intra-discal injection; Mesenchymal stem cells; Regenerative medicine; Safety