| CTRI Number |
CTRI/2021/09/036115 [Registered on: 01/09/2021] Trial Registered Prospectively |
| Last Modified On: |
08/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Stem Cell Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effects of stem cells in patients with Acute Respiratory Distress Syndrome Caused by Pneumonia due to COVID-19 |
|
Scientific Title of Study
|
A Label Extension, Single Arm, Multicentric, Two Dosage, Phase III Study Assessing the Efficacy and Safety of Intravenous Administration of stempeucel® (Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells) in Patients with Moderate to Severe Acute Respiratory Distress Syndrome due to COVID-19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRPL/ARDS/21-22/001 version 1.0 dated10 May 21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pawan Kumar Gupta |
| Designation |
Sr VP – Medical & Regulatory Affairs |
| Affiliation |
Stempeutics Research |
| Address |
Stempeutics Research
3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd.
#143, 212-215, EPIP Industrial Area
K R Puram Hobli, Bengaluru
Bangalore
KARNATAKA
560048
India |
| Phone |
08025028101 |
| Fax |
|
| Email |
pawan.gupta@stempeutics.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan Kumar Gupta |
| Designation |
Sr VP – Medical & Regulatory Affairs |
| Affiliation |
Stempeutics Research |
| Address |
Stempeutics Research
3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd.
#143, 212-215, EPIP Industrial Area
K R Puram Hobli, Bengaluru
Bangalore
KARNATAKA
560048
India |
| Phone |
08025028101 |
| Fax |
|
| Email |
pawan.gupta@stempeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Jijy Abraham |
| Designation |
Asst. Manager-Regulatory Affairs and Clinical Trials |
| Affiliation |
Stempeutics Research |
| Address |
Stempeutics Research
3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd.
#143, 212-215, EPIP Industrial Area
Bangalore
KARNATAKA
560048
India |
| Phone |
9900245795 |
| Fax |
|
| Email |
jijy.abraham@stempeutics.com |
|
|
Source of Monetary or Material Support
|
| Stempeutics Research Pvt Ltd
3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd.
#143, 212-215, EPIP Industrial Area
K R Puram Hobli, Bengaluru – 560 048
|
|
|
Primary Sponsor
|
| Name |
Stempeutics Research Pvt Ltd |
| Address |
3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd.
#143, 212-215, EPIP Industrial Area
K R Puram Hobli
Bengaluru – 560 048 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shibu Raj PS |
Dr.SM CSI Medical College Hospital |
Dr.SM CSI Medical College Hospital
Parassala Vellarada Rd, Karakonam, Kerala,India- 695504
Thiruvananthapuram
KERALA |
7558939404
drshiburajps21@gmail.com |
| Dr Vinod PB |
Elite Mission Hospital |
Elite Mission Hospital
PB No.1414
Koorkkenchery, Thrissur,
Kerala-680007, India
Thrissur
KERALA |
964576743
drvinodpbaburajan1989@gmail.com |
| DrMohammed Mirvaz Zulfikar |
Malabar Medical College Hospital and Research Centre |
Malabar Medical
College Hospital and Research
Centre
P.O. Modakkallur, Atholi,
Kozhikode:-673323, India
Kozhikode
KERALA |
9895714189
mohammedmzulfikar@gmail.com |
| Dr Harish Mallapura Maheshwarappa Principal Investigator |
Narayana Health Hospital,Bangalore |
Narayana Health 3rd Floor MICU. Dept. of Critical Care Medicine
Mazumdar Shaw Medical Centre, A Unit of NH Narayana
258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road
Bangalore
KARNATAKA |
8095218493
dr.harishmm@rocketmail.com |
| Dr Changalva Premdeep |
Vijaya Super Speciality Hospital |
Vijaya Super Speciality Hospital Room-7 16-II/41
Raghava Cini Complex, Nellore-524001 Andhra Pradesh, India
Nellore
ANDHRA PRADESH |
9010698756
premdrswetha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Human Ethics Committee Dr. SMCSI Medical College Karakonam Thiruvananthapuram |
Submittted/Under Review |
| Institutional Ethics Committee Elite Mission Hospital Koorkkenchery Thrissur |
Approved |
| Institutional Ethics Committee Malabar Medical College Hospital Modakkallur Atholi Kozhikode |
Approved |
| Narayana Health Medical Ethics Committee |
Approved |
| VIJAYA ETHICS COMMITTEE VIJAYA SUPER SPECIALITY HOSPITAL RAGHAVA CINI COMPLEX ROAD POGHATOTA NELLORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Single Arm Study Not Applicable |
| Intervention |
Stempeucel® (Ex - vivo cultured allogeneic Mesenchymal stromal cells) |
Dose of 200 million cells at Day 0 and Day 4 ± 1 day IV infusion ( total of two infusion) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Males or females of age 18 to 65 years of Indian origin and diagnosed with COVID-19 by reverse transcription polymerase chain reaction (RT-PCR)/TrueNat/CBNAAT assay.
2. Informed consent by the patient or his/her legal representative in case the patient is not capable of giving the consent.
3. Patients diagnosed with COVID-19 causing moderate and severe ARDS as per the Berlin ARDS definition.
a. Respiratory failure within one week of a known clinical insult or new and/or worsening respiratory symptoms
b. Respiratory failure not fully explained by cardiac failure or fluid overload
c. Moderate to severe hypoxemia must be present, defined as the ratio of PaO2/FiO2 with PEEP ≥5 cmH2O or non-ventilated
• Moderate ARDS: PaO2/FiO2 >100 mmHg and ≤200 mmHg with PEEP ≥5 cmH2O, or non-ventilated or Severe ARDS: PaO2/FiO2 ≤100 mmHg with PEEP ≥5 cmH2O, or non-ventilated
d. Bilateral opacities
4. Patients who can start receiving BMMSCs within 72 hours after the diagnosis of ARDS |
|
| ExclusionCriteria |
| Details |
1. Any other cause of ARDS not attributable to SARS-CoV2.
2. Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments in the opinion of the investigator.
3. Presence of any active malignancy.
4. Any end stage organ disease as assessed by investigator which may possibly affects the safety of the study drug.
5. Patient with history of any stem cell transplant in the past.
6. Moderate to severe liver failure (Child – Pugh’s score > 12).
7. Patient with chronic respiratory disease or use of ventilator at home.
8. Patients for whom 72 hours or longer has passed since the attachment of ventilator.
9. Patient with pulmonary transplant or having history of lung lobectomy.
10. Patient with clinically findings consistent with diffuse alveolar haemorrhage.
11. Patients with mean arterial (blood) pressure < 60 mmHg despite treatment with one or more vasopressor or vasoactive agent.
12. Patients who are appropriate to be treated with extracorporeal membrane oxygenation (ECMO) at screening or currently receiving ECMO.
13. Patients who were resuscitated after cardio-respiratory arrest.
14. Patients with uncontrolled co-morbidities like hypertension, diabetes mellitus etc., as per investigator discretion
15. Patients who are under artificial dialysis at screening.
16. Patient documented to have deep venous thrombosis or pulmonary embolism within last 3 months.
17. Patients with a history of myocardial infarction within 6 months before screening.
18. Women of childbearing age who are not using an adequate method of contraception. If the patient is menopausal, it must be documented.
19. Pregnancy or breast feeding.
20. Patient with HIV infection.
21. Patient expected to have hypersensitivity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent mortality 28 days after administration of BMMSCs |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ICU free days 28 days after administration of BMMSCs
Number of days alive and off ventilatory support at 28 days
Oxygen index changes (from Day 0 to Day 14: Day 0, 1, 4, 7 and 14 or on the day of hospital discharge)
APACHE II score (from Day 0 to Day 14: Day 0, 1, 4, 7 and 14 or on the day of hospital discharge)
SOFA score (from Day 0 to Day 14: Day 0, 1, 4, 7 and 14 or on the day of hospital discharge)
Mortality at Day 56 and Day 84
|
28 days efficacy & 1 year safety follow up |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 3 |
|
Date of First Enrollment (India)
|
06/09/2021 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a A Label Extension, Single Arm, Multicentric, Two Dosage, Phase III Study Assessing the Efficacy and Safety of Intravenous Administration of stempeucel® (Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells) in Patients with Moderate to Severe Acute Respiratory Distress Syndrome due to COVID-19 |