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CTRI Number  CTRI/2020/08/027043 [Registered on: 09/08/2020] Trial Registered Prospectively
Last Modified On: 29/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Stem Cell Therapy 
Study Design  Single Arm Trial 
Public Title of Study   Mesenchymal Stem Cell Therapy For Covid 19  
Scientific Title of Study   A Phase 1 clinical trial of intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in patients with novel COVID-19 virus pneumonia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT-06/2020  DCGI 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alok Sharma 
Designation  Professor & Head, Department of Neurosurgery and Director 
Affiliation  LTMG Hospital & LTM Medical College and NeuroGen Brain and Spine Institute 
Address  NeuroGen Brain and Spine Institute Directors Room, 2nd floor Plot 19, Sector 40, Nerul (W), Next Seawoods Grand Central Station. Off Palm Beach Road. Navi Mumbai- 400706. India
Neurosurgery Department, LTM Medical College and General Hospital, Sion, Mumbai 400022
Thane
MAHARASHTRA
400706
India 
Phone  9820046663  
Fax    
Email  alok276@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rohit Kulkarni 
Designation  Director 
Affiliation  ReeLabs Pvt. Ltd. 
Address  ReeLabs Pvt. Ltd. 1st Floor, KK Chambers, Sir P.T. Road, Fort, Mumbai

Mumbai
MAHARASHTRA
400001
India 
Phone  9820526618  
Fax    
Email  drrohitrkulkarni@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhijit Bopardikar 
Designation  Director 
Affiliation  ReeLabs Pvt. Ltd. 
Address  ReeLabs Pvt. Ltd. 1st Floor, KK Chambers, Sir P.T. Road, Fort, Mumbai

Mumbai
MAHARASHTRA
400001
India 
Phone  9820128181  
Fax    
Email  asb@reelabs.com  
 
Source of Monetary or Material Support  
Neurogen Brain and Spine Institute Plot 19, Sector 40, Nerul (W), Next Seawoods Grand Central Station. Off Palm Beach Road. Navi Mumbai- 400706. India 
ReeLabs Pvt.Ltd ReeLabs Pvt. Ltd. 1st Floor, KK Chambers, Sir P.T. Road, Fort, Mumbai-400001 
 
Primary Sponsor  
Name  Neurogen Brain and Spine Institute 
Address  Plot 19, Sector 40, Nerul (W), Next Seawoods Grand Central Station. Off Palm Beach Road. Navi Mumbai- 400706. India 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
ReeLabs Pvt Ltd  1st Floor, KK Chambers, Sir P.T. Road, Fort, Mumbai - 400 001 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alok Sharma  Lokmanya Tilak Municipal Medical College and General Hospital  Department of neurosurgery, Dr. Babasaheb Ambedkar Road, Sion (West), Mumbai - 400022
Mumbai
MAHARASHTRA 
9820046663

alok276@gmail.com 
Dr Alok Sharma  Seven Hills Hospital  Seven Hills Hospital, Marol Maroshi Rd, Shivaji Nagar JJC, Marol, Andheri East, Mumbai, Maharashtra 400059
Mumbai (Suburban)
MAHARASHTRA 
9820046663

alok276@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Lokmanya Tilak Municipal Medical College and General Hospital  Approved 
Lokmanya Tilak Municipal Medical College and General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mesenchymal Stem Cells   Mesenchymal Stem cells derived from umbilical cord and placenta  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients admitted with RT-PCR confirmed COVID-19 illness.
Age: 18-65 years without any uncontrolled comorbidities like hypertension, diabetes, renal failure, etc
Written informed consent
Has any of the two
PaO2/ FiO2: 200-300
Respiratory Rate > 24/min and SaO2 ≤ 93% on room air 
 
ExclusionCriteria 
Details  Pregnant women
Breastfeeding women
Critically ill patients:
P/F ratio < 200 (ARDS )
Shock (Requiring Vasopressor to maintain a MAP ≥ 65mmHg or MAP below 65)
Patients with other severe co-morbidities like cancer, chronic renal, chronic liver failure and chronic cardiac failure. This will not include diabetes, hypertension, etc
Participating in any other clinical trial 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Avoidance of -
Progression to severe ARDS (P/F ratio 100) and All-cause Mortality at 28 days
2. Oxygenation Index : SpO2
3. Multi Organ Function: CBC,LFT,Serum Creatinine,Electrolytes,
4. Troponin and Myoglobin
5. Clinical measures: Fever and Respiratory Rate
6.Immediate Adverse Events occurring after IV administration of MSCs
7. Other adverse events e.g. Pulmonary embolism, Stroke, Arrhythmias, Liver failure 
All Days 
 
Secondary Outcome  
Outcome  TimePoints 
Time to recovery on 8 Point ordinal scale
Time to symptom resolution (Fever, Cough, Shortness of Breath)
Duration of Hospital stay after intervention
Change in SOFA
Duration of respiratory support required (Invasive mechanical ventilation and non invasive)
Radiological improvement (Chest X Ray/ Chest CT scan)
Duration of conversion of positive to negative Covid 19 from RT PCR
Levels of CRP, IL6, TNF-alpha, Ferritin, CD3, CD4, CD4/CD8 
Lab parameters- Day 0, 2,4,6,8, 14 days
Xray- 0,7,14,21,28 days and 6 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   10/08/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary   This is a phase 1 safety study to be conducted in patients with novel Covid 19 virus pneumonia administered with mesenchymal stem cells derived from umbilical cord and placenta. This product is manufactured in a cGMP facility, licensed by CDSCO and FDA.The product has undergone all mandatory preclinical and characterization studies and analysis and is approved for use in humans to treat COVID-19 afflicted patients by CDSCO/DCG(I) as per the New Drugs and Clinical Trial Rules, 2019.
The study will be conducted in 20 patients. The dosage administered will be 100 million cells in 10 patients and 200 million cells in 10 patients in two doses on day 1 and day 4 along with standard care. Safety and efficacy of the MSCs will be studied as primary and secondary end points.  
 
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