Clinical Trials & INDs

June 2020: SanoStem wants to do a clinical trial in India using Stemedica’s Ischemic-Tolerant Mesenchymal Stem Cells (itMSC) to treat COVID-19-related Lung Damage and Acute Respiratory Distress Syndrome (ARDS) for free in 10-20 patients. SanoStem is very confident that the results will show benefit in these severe diseases, for which there is no good current treatment.

May 2020: ProMedica Hospital, Toledo, Ohio: 6 seriously ill COVID-19 patients with lung disease treated successfully under Expanded use IND approved by FDA:  https://www.dropbox.com/s/kkgz30ryjsetkp9/ProMedica%20Letter%20May11%2C%202020.pdf?dl=0

April 2020: Providence Center, Santa Monica, CA: 1 seriously ill COVID-19 patient with lung disease treated successfully under Emergency Use IND approved by FDA: http://www.stemedica.com/first-covid-19-patient-treated-under-emergency-use-ind-at-providence-saint-johns-health-center-using-stemedica-ischemia-tolerant-allogeneic-mesenchymal-bone-marrow-cells-2/

May 2018: SanoStem has applied to CDSCO for approval of a Phase II/III clinical trial using itMSC for Type 2 Diabetes Mellitus (T2DM) in India. The principal investigators will be: Dr. Anil Bhansali, Professor & Head of Department, PGIMER, Chandigarh and Dr. Sandeep Kumar Mathur, Professor & Head of Department, S.M.S Medical College, Jaipur, Govt. of Rajasthan. The application is still pending waiting for additional clarification.

August 2014: SanoStem received approval from the Health Authority of Fiji to begin a clinical trial for ischemic stroke using both itNSC & itMSC.

2013-2020: Stemedica has FDA approval for 6 Phase I/IIa clinical trials in USA:

  • Ischemic Stroke – Phase IIa completed and published.
  • Congestive Heart Failure (CHF) Phase IIa completed & published. 
  • Acute Myocardial Infarction (AMI) 
  • Cutaneous PhotoAging
  • Alzheimer’s Disease (AD)
  • Traumatic Brain Injury (TBI)

2010-2013: National Scientific Medical Center, Astana, Kazakhstan: Several patients treated with variety of neurological disorders with MSC and NSC with success.15 Patient Analysis from Kazakhstan itNSC & itMSC Treatments 

2001-2012: National Scientific Medical Center, Astana, Kazakhstan: Over 1,000 patients treated with MSC for Type 2 Diabetes Mellitus with success: Diabetes results in Kazakhstan itMSC Treatments