Table 2.
Ongoing clinical trials as of May 2018 investigating stem cell therapies for SCI (Source:Clinicaltrials.gov).
| Title (ClinicalTrials.gov Identifier) | Responsible party/study location | Condition(s) of interest/intervention(s) of interest | Study overview | Phase, estimated completion, and status |
|---|---|---|---|---|
| A Phase-1, Open-label, Single-Site, Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI (NCT01772810) (275) | Joseph Ciacci (PI); UCSD Medical Center; Neuralstem Inc; San Diego, CA, USA | Spinal Cord Injury/human spinal cord stem cell implantation in paralysis patients with SCI | Seeking 8 participants; 4 to enroll in Group A (cord injury at T2-T12) or Group B (cord injury at C5-C7); 6 month study period post-op; follow-up period of 54 months | Phase 1/Recruiting; Estimated Completion: Dec 2022 |
| The Efficacy and Safety of NeuroRegen Scaffold ™ Combined with Mesenchymal Stem Cells or Neural Stem Cells for Chronic Spinal Cord Injury Repair (NCT02688049) (276) | Jianwu Dai (PI); Chinese Academy of Sciences; Affiliated Hospital of Logistics University of CAPF, Tianjin, China | Spinal Cord Injury/NeuroRegen scaffold-MSC transplantation; Neuroregen scaffold-NSC transplantation | Randomized, double-blind clinical trial with 30 participants; two experimental arms (NeuroRegen scaffold-MSC transplantations OR NeuroRegen scaffold- NSC transplantation after SCI); in both arms, patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million MSCs and NSCs, respectively; they will also undergo comprehensive rehabilitation, | Phase 2/Recruiting; Estimated Completion: June 2018 |
| Safety and Efficacy of Autologous Neural Stem Cell Transplantation in Patients with Traumatic Spinal Cord Injury (NCT02326662) (277) | Alexander Averyanov (PI); Federal Research Clinical Center of Federal Medical & Biological Agency, Russia, | Spinal Cord Injury/Transplantation of autologous MSC-derived NSCs with a 3D biomatrix | Non-randomized interventional clinical trial involving 30 participants; testing the safety and efficacy of autologous MSCderived NSCs transplantation in paraplegic and tetraplegic patients in the acute, sub-chronic, and chronic phases of SCI; | Phase 1/2/Active, not recruiting; Estimated completion: Oct 2018 |
| Transplantation of Purified Autologous Bone Marrow- or Leukapheresis-Derived CD34+ and CD133+ for Patients with Spinal Cord Injuries: A Long-Term Comparative Evaluation of Safety and Efficacy Study (NCT02687672) (278) | Stem Cells Arabia; Amman, Jordan | Spinal Cord Injury/Transplantation of unmanipulated, autologous CD34+ and CD133+ stem cells | Randomized interventional clinical trial seeking 50 participants for enrollment to one of two experimental arms (injection of leukapheresis-deprived, purified, autologous CD34+ and CD133+ stem cells OR injection of bone marrow derived, purified, autologous CD34+ and CD133+ stem cells); individuals will be monitored over a 60-month time period | Phase 1/2/Active, not recruiting; Estimated Completion: Dec 2021 |
| The Effect of Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells in Patients with Late Stage of Chronic Spinal Cord Injury: A Multicenter, Prospective, Cohort Study (NCT03505034) (279) | Limin Rong; Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China | Spinal Cord Injury/Intrathecal transplantation of Umbilical Cord MSCs | Part of a larger study to assess the safety and efficacy of intrathecal transplantation of allogeneic umbilical-cord derived MSCs for treatment of SCI in different phases; the present study will enroll 96 participants in a single group, assessing the intervention of interest in patients with late stage chronic SCI (more than 12 months post-injury); patients will receive | Phase 2/Recruiting; Estimated Completion: Dec 2018 |
| A Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients with Chronic Spinal Cord Injury (NCT01676441) (280) | Sangryong Jeon (PI); Pharmicell Co, Ltd.; Asan Medical Center, Songpagu, Seoul, Republic of Korea | Spinal Cord Injury/Autologous bone marrowderived mesenchymal stem cell transplantation directly into the injured spinal cord | Interventional single-center clinical trial with 32 participants; patients with cervical spinal cord injuries undergo a posterior cervical laminectomy and MSC transplantation; following laminectomy, 1.6 × (10∧7) and 3.2 × (10∧7) autologous MSCs are injected into the intramedullary and intrathecal space; subjects also receive 4 weeks of physical and | Phase 2/3; Active, not recruiting; Estimated Completion: Dec 2020 |
| Umbilical Cord Mesenchymal Stem Cells Transplantation for the Treatment of Spinal Cord Injury (NCT02481440) (281) | Limin Rong; Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China | Spinal Cord Injury/Subarachnoid injection of human allogeneic umbilical cord-derived MSCs | Randomized double-blind trial with 44 participants; two arms (experimental—patients with SCI receive intrathecal administration of up to 1 × (10∧6) umbilical cord MSCs per kg every month for 4 months; control—no umbilical cord MSC transplantation) | Phase 1/2; Recruiting; Estimated Completion: Dec 2018 |
| The Effect of Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells in Patients with Sub-Acute Spinal Cord Injury: A Multicenter, Randomized, Controlled Trial (NCT03521336) (282) | Limin Rong; Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China | Spinal Cord Injury; Intrathecal transplantation of umbilical cord-derived MSCs | Randomized trial with 130 subjects; single-masking; two arms (experimental—subjects receive intrathecal transplantation of umbilical cord MSCs (1 × (10∧6) cells/kg) once a month for 4 months; control—placebo sham operation with 10 ml saline, once a month for 4 months) | Phase 2/Recruiting; Estimated Completion: Dec 2022 |
| The Effect of Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells in Patients With Early Stage of Chronic Spinal Cord Injury: A Multicenter, Randomized, Controlled Trial (NCT03521323) (283) | Limin Rong; Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China | Spinal Cord Injury; Intrathecal transplantation of umbilical cord-derived MSCs | Randomized, single-masked, multi-center trial with 92 participants; two arms (experimental—subjects receive intrathecal transplantation of umbilical cord MSCs (1 × (10∧6)cells/kg) once a month for 4 months; control—placebo sham operation and 10 ml saline, once a month for 4 months) | Phase 2/Recruiting; Estimated Completion: Dec 2022 |
| Randomized Clinical Trial for the Evaluation of Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury (NCT02574585) (284) | Ricardo Ribeiro-dos-Santos (PI); Hospital Sao Rafael, Brazil | Spinal Cord Injury/Autologous Mesenchymal Stem Cells Transplantation | Randomized, non-placebo controlled, prospective clinical trial enrolling 40 patients with SCI for at least 12 months with thoracolumbar chronic and complete spinal cord injury (ASIA grade A); two arms (experimental–20 subjects randomly assigned to receive 2 percutaneous injections of MSCs with a 3- month interval between injections; control−20 subjects randomly assigned to be clinically followed, without specific interventions) | Phase 2/Not Yet Recruiting; Estimated Completion: Jan 2022 |
| Comparative Evaluation of Safety and Effectiveness of Autologous Bone Marrow Derived Mesenchymal Stem Cells (BM-MSC) vs. Adipose Tissue Derived Mesenchymal Stem Cells (AT-MSC) in the Treatment of Spinal Cord Injury (SCI) Patient (NCT02981576) (285) | Abdalla Awidi (Study Chair); Cell Therapy Center, University of Jordan, Amman, Jordan | Spinal Cord Injury/Autologous Mesenchymal Stem Cells Transplantation | 14 SCI patients will be recruited and blindly divided into two different treatment groups (group 1: receive autologous MSCs from adipose tissue by intrathecal injection, 3x; group 2: receive autologous MSCs from bone marro by intrathecal injection, 3x) | Phase 1/2; Active, not recruiting; Estimated Completion: Jan 2019 |
| Phase I Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury (NCT03308565) (286) | Wenchun Qu (PI); Mayo Clinic, Rochester, MN, USA | Spinal Cord Injury/Paralysis/Autologous, adipose-derived MSCs (AD-MSCs) | Open-label, prospective safety and feasibility study of intrathecal injection of autologous culture-expanded adiposederived MSCs in patients with severe SCI; seeking 10 participants who will undergo a minor procedure to obtain adipose tissue for isolation and expansion of adipose-derived MSCs; autologous ADMSCs will then be transplated through intrathecal injection at L4-5 undero fluoroscopic guidance at single dose of 100 million cells; evaluation postinjection at day 2, 3, week 1, 2, 4, 24, 48, 72, and 96 | Phase 1: Recruiting; Estimated Completion: Nov 2023 |
| Evaluation of the Safety and Potential Effectiveness of Autologous Mesenchymal Stem Cells Transplantation in Subjects with Cervical Chronic and Complete Spinal Cord Injury (NCT02574572) (287) | Ricardo Ribeiro-dos-Santos (PI); Hospital Sao Rafael, Brazil | Spinal Cord Injury/Autologous Mesenchymal Stem Cells Transplantation | 10 participants will be enrolled to a single group that will undergo laminectomy and autologous MSC intralesional injection | Phase 1; Recruiting; Estimated completion: June 2020 |
| Open Label Study of Autologous Bone Marrow Mononuclear Cells in Spinal Cord Injury (NCT02009124) (288) | Alok K Sharma (PI); Neurogen Brain and Spine Institute, Mumbai, Maharashtra, India | Spinal Cord Injury/Autologous bone marrow mononuclear cell transplantation | Seeking to recruit 500 participants for a non-randomized, open label clinical trial with an experimental group (bone marrow is aspirated and mononuclear cells separated, injected intrathecally by standard lumbar puncture procedure) and control group (no stem cell therapy); will assess change in clinical symptoms and functional independence | Phase 2; Recruiting; Estimated completion: Dec 2018 |
| Safety and Efficacy of NeuroRegen Scaffold™ with Bone Marrow Mononuclear Cells or Mesenchymal Stem Cells for Chronic Spinal Cord Injury (NCT02352077) (289) | Jianwu Dai (PI); Chinese Academy of Sciences; Affiliated Hospital of Logistics University of CAPF, Tianjin, China | Spinal Cord Injury/NeuroRegen scaffold with BMMCs or MSCs transplantation | 30 participants, all patients with chronic SCI (ASIA grade A) receiving NeuroRegen Scaffold with BMMCs or MSCs transplantation, followed by comprehensive rehabilitation, psychological and nutritional measures; assessing improvements in neurophysiological measures, independence and quality of life, pain, urinary and bowel function | Phase 1; Enrolling by invitation; Estiamted completion: Dec 2018 |
| A Phase I/Iia, Randomized, Double-blind, Single-dose, Placebo Controlled, Two-way Crossover Clinical Trial to Assess the Safety and to Obtain Efficacy Data in Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury (NCT03003364) (290) | Joan Vidal (PI); Hospital de Neurorehabilitacio Institut Guttmann; Badalona, Barcelona, Spain | Spinal Chord Injury, Chronic/XCEL—UMCBETA (Expanded MSC from Wharton Jelly) | Phase I/Iia, randomized, double-blind, single-dose, placebo controlled, two-way crossover clinical trial; 10 patients (18–65 years old) affected by chronic traumatic SCI; patients in the experimental group will receive an intrathecal injection of XCEL-UMC-BETA, followed by placebo at month 6; patients in the placebo group will receive placebo until month 6, when they will receive XCEL-UMC-BETA | Phase 1/2; Active, not recruiting; Estimated completion: April 2020 |
| Stem Cell Spinal Cord Injury Exoskeleton and Virtual Realtiy Treatment Study (NCT03225625) (291) | Jeffrey Weiss and Steven Silberfarb (Pis); Steven Levy (Study Director); The Healing Institute, Margate, Florida, USA | Spinal Cord Injuries/Bilateral paraspinal injects of BMSCs at the level of injury, superior and inferior to the spinal segment, followed by intravenous injection and intranasal placement; in addition to exoskeletal movement or virtual reality visualization | 40 participants, non-randomized; assignedto one of three arms (Arm 1: BMSC paraspinal, IV, intranasal; Arm 2: BMSC paraspinal, IV, intranasal and exoskeleton; Arm 3: BMSC paraspinal, IV, intranasal and virtual reality); will assess autonomic nervous system function, quality of life, and ASIA Impairment Scale | N/A ; Recruiting; Estimated Completion: July 2022 |
| Clinical Trial of Phase 1/2 to Evaluate the Feasibility, Safety, Tolerability and Preliminary Efficacy of the Administration of FAB117–HC, a Drug Whose Active Ingredient is HC016, Allogeneic Adipose Derived Adult Mesenchymal Stem Cells Expanded and Pulsed with H2O2, in Acute Traumatic SCI Patients (NCT02917291) (292) | Juana Maria Barrera Chacon (PI), Hospital Universitario Virgen del Rocio, Unidad de Lesionados Medulares, Sevilla, Spain; Miguel Angel Gonzalez Viejo (PI), Hospital Vall d'Hebron, Unidad de Lesionados Medulares, Barcelona, Spain; Antonio Rodriguez Sotillo (PI), Complexo Hospitalario Universitario A Coruna, Unidad de Lesionados Medulares, A Coruna, Spain | Acute Traumatic Spinal Cord Injury/FAB117– HC (HC016, allogeneic adipose-derived mesenchymal stem cells expanded and pusled with H2O2) | 46 participants; randomized, double-blind study with 3 arms (FAB117–HC (ph1) – 3 patients who will receive an intramedullary administration of FAB117– HC (20 million cells) and 3 patients who will receive 40 million cells; Control group (ph2) of 20 patients receiving no treatment; FAB117-HC (Ph2) with 20 patients receiving intramedullary administration of the maximum tolerated dose (either 20 or 40 million cells)); assessing number of adverse events; changes in neurological function, | Phase 1/2; Recruiting; Estimated completion: Jan 2020 |
| A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects with Subacute Cervical Spinal Cord Injury (NCT02302157) (293) | Edward D Wirth III (Study Director); University of California at San Diego; Rancho Los Amigos/USC, Stanford University/Santa Clara Valley Medical Center; Shepard Center, Atlanta, GA; Rush University Medical Center, Chicago, IL; Indiana University, Indianapolis, IN; Washington University, Saint Louis, MI; Thomas Jefferson University/Magee Rehabilitation, Philadelphia, PA; Medical College of Wisconsin, Milwaukee, WI | Cervical Spinal Cord Injury, Spine Injury, Spinal Cord Trauma / AST-OPC1 | Open label, single group assignment with 35 participants; participants will receive one injection of 2 or 10 million AST-OPC1 cells, or 2 injections of 10 million AST-OPC1 cells for a total of 20 million cells; cohort dependent; will assess number of adverse events within 1 year and neurological function | Phase 1/2; Active, not recruiting; Estimated Completion: Dec 2018 |