| 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 Study |
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |