@article{viswanathan2013clinical,
  title = {Clinical Safety and Efficacy of Autologous Mesenchymal Stem Cells in Spinal Cord Injury: A Clinical Trial Report},
  author = {Chandra Viswanathan and Prathibha Shetty},
  year = 2013,
  url = {https://ibimapublishing.com/articles/ASC/2013/679731/},
  journal = {Advances in Stem Cells},
  volume = 2013 (2013),
  pages = 13,
  doi = 10.5171/2013.679731,
  abstract = {Background: The treatment of Spinal cord injuries (SCI) poses a major challenge to the medical fraternity. In this regard, autologous stem cells, such as bone marrow derived mesenchymal stem cells, (BMMSCs) could be an attractive option for treating SCI patients to some extent. However clinical studies are necessary for transferring preclinical findings from animal experiments to humans. We investigated the transplantation of autologous BMMSCs in patients with acute SCI with respect to safety, therapeutic time window, implantation strategy, number of doses and functional improvement. We report data from 20 patients (1:1) enrolled for the study with complete or partial transaction as shown by MRI. We report data of 20 patients who received transplants 6 weeks post injury. The follow up examination was done at 6 weeks, 12 weeks, and 24 weeks after implantation by the neurologistics using the standard neurological scoring including the Frankel score along with the improvement in the sensory and motor functions. Objective: This study was a prospective, randomized, open-label parallel group clinical study. Out of the 10 patients, two of the subjects enrolled in the treatment group received three doses at the interval of a month between the doses. The 10 patients enrolled in the treatment arm received the autologous stem cells along with the standard care, while the other 10 subjects received the standard care alone. MRI evaluation of the lesion was also planned at the follow up visits. The functional responses and the improvement in the quality of life of patients receiving multiple doses of the autologous cells were compared with the patients receiving single dose of cells.  During the study period, patients were given standard care for management of acute SCI including surgery, decompression, immobilization etc. Results: Patients enrolled in treatment arm (R-HSC-001 + Standard Care of management) with spinal cord injury have shown better improvement in motor function as assessed by Frankel score as compared to control arm (Standard Care of management alone). 6 (66.67%) patients showed at least 1 grade improvement in Frankel score in treatment arm as compared to 2 patients (33.33%) in the control arm at the end of treatment. Patients who received three doses of investigational product have shown maximum improvement in Frankel score (improved from A to D). Muscle power improved in 4 patients (including two subjects who received three doses of IP) enrolled in treatment arm while in one patient enrolled in control arm. In treatment arm, patients who received three doses have shown better improvement in neurological function, as compared to patients who received only one dose of investigational product.6 (66.67%) patients showed improvement in sensory perception in treatment arm as compared to 2 (33.33%) patients in control arm at the end of 24 weeks. 
Conclusion:
1.    At the end of the study, we could conclude that autologous BMMSCs was safe, well tolerated, easy to administer and efficacious to treat patients with spinal cord injury with the overall improvement in the quality of life. 
2.    Patients receiving multiple doses showed a maximum improvement in neurological functions with the overall improvement in the quality of life.
3.    There was no safety concern in patients who received three doses of investigational product indicating the cells to be safe in multiple doses.
4.    The frequency of adverse events was less in treatment arm as compared to control arm. In addition, there was no death reported in the test arm, hence stem cell therapy was found to be effective to recover the neurological functions. 
5.    Trials involving a larger population of patients, multiple routes and different cells doses are needed before further solid conclusion can be drawn.},
  keywords = {Autologous bone marrow, mesenchymal stem cells, spinal cord injury, multiple doses},
  note = Article ID: 679731
}