COVID-19Phase 2NCT04444271
Mesenchymal Stem Cell Infusion for COVID-19 Infection
A Phase 2 study testing Mesenchymal stem cells in people with COVID-19, run by Dr. Zaineb Akram at 1 site in Pakistan.
Trial summary
Since the outbreak of coronavirusdisease2019(COVID-19), many researchers in China have carried out/published clinical trials on treatment based on Western medicine, traditional Chinese medicine or a combination of the two. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2020to 30 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female, aged ≥ 10years
- Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; and
- Moderate illness: In compliance with the 2019-coronavirus pneumonia diagnosis standard [according to the novel coronavirus infection pneumonia diagnosis and treatment program (Trial Implementation Version 6) issued by the National Health and Medical Commission, and world health organization (WHO) 2019 new coronavirus guidelines standards]: (A) increased breathing rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; (B) in resting state, means oxygen saturation ≤93%; (C) partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa);
- Critically ill : Respiratory failure, Septic Shock, muti-organ dysfunction syndrome (MODS)
Who cannot join
- Patients with systemic autoimmune diseases
- Not consenting for clinical trial
- Those declared not for resuscitation due to underlying comorbid or current critical condition
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
NIBMT
Rawalpindi, Punjab Province, 46000
Xanab Akram, 03325346564
About this study
Official title: Prospective, Randomized Phase 2 Clinical Trial of Mesenchymal Stem Cells(MSCs) for the Treatment of Coronavirus Disease 2019(COVID-19)
Since the outbreak of coronavirusdisease2019(COVID-19), many researchers in China have carried out/published clinical trials on treatment based on Western medicine, traditional Chinese medicine or a combination of the two. Trials on treatment modalities have mainly used antivirals, interferon, glucocorticoids in addition to traditional Chinese medicine. There are also clinical trials exploring hydroxyquinoline/chloroquine sulphate, immunoglobulins, Vitamin-C, washed microbiota, nebulized interferon, teicoplanin as well as Mesenchymal stem cells. However, most of these trials were small (median sample size 100) and the bulk of potential therapeutic strategies remain in the experimental phase and currently there is no effective specific antiviral with high-level evidence.The aim of this study is assess the efficacy of MSCs as an add-on therapy to standard supportive treatment for patients with moderate/severe COVID-19.
Read the detailed description
All patients will receive 2x10^6 cells/kg on days 1 and day 7 (if needed). The study will be divided in 2 phases. In the first phase, 10 patients will be included and randomized to 2 groups (5 Treatment arm; 5 Control Arm) and receive 2 x10^6 cells/kg MSCs on days 1 and 7 in addition to standard care. Thereafter, the trial committee will meet and evaluate all collected safety and efficacy information to decide about crossover of Control arm to treatment arm if patient deteriorates clinically while in Control arm. Then, 10 new subjects will be included in the study and treated according to protocol.
Preparation of MSCs doses MSCs will be isolated from bone marrow harvested cells. About 50ml bone marrow will be collected from iliac crest using aseptic technique in syringes primed with anticoagulant. The collected sample will be diluted with Phosphate Buffer Saline (PBS) and MSCs will be separated using density gradient centrifugation. After resuspension the cells will be seeded at a fixed concentration of 100,000 cells/cm2 in specially designed flasks and incubated at 37oC in 5% carbondioxide (CO2). Medium will be changed after every third day till harvesting of MSCs from the flasks. Once confluent (approximately day 20) the cells will be harvested with sterile techniques using Trypsin- Ethylenediaminetetraacetic acid ( EDTA ) solution. The prepared cells can either be stored in 50ml cryogenic vials for future use or infused immediately.
Patient Selection and MSCs demand Patient for MSCs and Control arm will be selected by multidisciplinary team (MDT) comprising Critical Care Specialist, Pulmonologist, Infectious Disease Specialist, Clinical Hematologist.
- Demand for MSCs will be initiated on pre-designated forms , signed by Critical care Specialist Clearly indicating indication of MSCs.
- Request form will be sent Stem Cell Lab.
- Incharge stem Cell Lab will authorize issuance of the MSCs dose.
- Stem Cell Lab will issue the dose Administration of MSCs
- Experimental arm: Frozen MSCs will be resuspended in 100ml normal saline for immediate use and given intravenously. The patients should be pre-medicated to avoid allergic reactions to third party MSCs. Each patient in Experimental arm will be given 2 x 106 cells/kg will be administered on day 1,7 in addition to supportive care 2. Control Arm: Will be Continued on supportive care
Proposed usage:
Because of the very limited availability of MSCs, their usage has to be rationalized by MDT comprising of pulmonologist, critical care specialist and clinical haematologist and Infectious disease specialist.There is not enough evidence to put forth therapeutic recommendations however, treatment decisions can be made on case to case basis after MDT.
- Conditions
- COVID-19
- Being tested
- Mesenchymal stem cells, Placebo
- Keywords
- Coronavirus, Mesenchymal Stem Cells, Survival
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellsDrug
Also called MSCs
- Frozen MSCs will be resuspended in 100ml normal saline for immediate use and given intravenously. The patients should be pre-medicated to avoid allergic reactions to third party MSCs. Each patient in Experimental arm will be given 2 x 106 cells/kg will be administered on day 1,7 in addition to supportive care
PlaceboOther
100 ml of normal saline will be given intravenously to control arm
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells | Experimental | 10 patients will be given mesenchymal stem cells at dose 2x10^6 cells/kg MSCs on days 1 and day 7 (if needed) in addition to standard care Receives: Drug: Mesenchymal stem cells |
| Placebo | Placebo comparator | Only supportive care will be given to 10 patients Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Assessment of Overall survival at 30 days post intervention
Measured: 30 days post intervention
Secondary outcomes (4)
Clinical improvement
days required for oxygen support independence after intervention
Measured: 30 days
Time of COVID19 PCR negativity
PCR testing to check PCR negativity
Measured: day 1,3,7,10, 14
Radiological improvement (day 15 and day 30 assessment)
Computed tomography Chest assesment will be done to assess improvment in radiological findings of COVID-19
Measured: day 15 and day30
days required to discharge from hospital
number of days required for discharge from hospital
Measured: 30 days post admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 May 2020
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Zaineb Akram
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr. Zaineb Akram, National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
- Investigators
- xanab akram, Study chair, NIBMT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444271
- Sponsor's protocol ID
- NIBMT-MSc-COVID-2020
- Status last verified
- Jun 2020
- First submitted
- 27 May 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Phase 2 Clinical Trial of Mesenchymal Stem Cells(MSCs) for the Treatment of Coronavirus Disease 2019(COVID-19)
- ClinicalTrials.gov ID
- NCT04444271
- Acronym / sponsor ID
- NIBMT-MSc-COVID-2020
- Conditions
- COVID-19
- Keywords
- Coronavirus, Mesenchymal Stem Cells, Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dr. Zaineb AkramOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since the outbreak of coronavirusdisease2019(COVID-19), many researchers in China have carried out/published clinical trials on treatment based on Western medicine, traditional Chinese medicine or a combination of the two. Trials on treatment modalities have mainly used antivirals, interferon, glucocorticoids in addition to traditional Chinese medicine. There are also clinical trials exploring hydroxyquinoline/chloroquine sulphate, immunoglobulins, Vitamin-C, washed microbiota, nebulized interferon, teicoplanin as well as Mesenchymal stem cells. However, most of these trials were small (median sample size 100) and the bulk of potential therapeutic strategies remain in the experimental phase and currently there is no effective specific antiviral with high-level evidence.The aim of this study is assess the efficacy of MSCs as an add-on therapy to standard supportive treatment for patients with moderate/severe COVID-19.
Detailed description
All patients will receive 2x10^6 cells/kg on days 1 and day 7 (if needed). The study will be divided in 2 phases. In the first phase, 10 patients will be included and randomized to 2 groups (5 Treatment arm; 5 Control Arm) and receive 2 x10^6 cells/kg MSCs on days 1 and 7 in addition to standard care. Thereafter, the trial committee will meet and evaluate all collected safety and efficacy information to decide about crossover of Control arm to treatment arm if patient deteriorates clinically while in Control arm. Then, 10 new subjects will be included in the study and treated according to protocol.
Preparation of MSCs doses MSCs will be isolated from bone marrow harvested cells. About 50ml bone marrow will be collected from iliac crest using aseptic technique in syringes primed with anticoagulant. The collected sample will be diluted with Phosphate Buffer Saline (PBS) and MSCs will be separated using density gradient centrifugation. After resuspension the cells will be seeded at a fixed concentration of 100,000 cells/cm2 in specially designed flasks and incubated at 37oC in 5% carbondioxide (CO2). Medium will be changed after every third day till harvesting of MSCs from the flasks. Once confluent (approximately day 20) the cells will be harvested with sterile techniques using Trypsin- Ethylenediaminetetraacetic acid ( EDTA ) solution. The prepared cells can either be stored in 50ml cryogenic vials for future use or infused immediately.
Patient Selection and MSCs demand Patient for MSCs and Control arm will be selected by multidisciplinary team (MDT) comprising Critical Care Specialist, Pulmonologist, Infectious Disease Specialist, Clinical Hematologist.
- Demand for MSCs will be initiated on pre-designated forms , signed by Critical care Specialist Clearly indicating indication of MSCs.
- Request form will be sent Stem Cell Lab.
- Incharge stem Cell Lab will authorize issuance of the MSCs dose.
- Stem Cell Lab will issue the dose Administration of MSCs
- Experimental arm: Frozen MSCs will be resuspended in 100ml normal saline for immediate use and given intravenously. The patients should be pre-medicated to avoid allergic reactions to third party MSCs. Each patient in Experimental arm will be given 2 x 106 cells/kg will be administered on day 1,7 in addition to supportive care 2. Control Arm: Will be Continued on supportive care
Proposed usage:
Because of the very limited availability of MSCs, their usage has to be rationalized by MDT comprising of pulmonologist, critical care specialist and clinical haematologist and Infectious disease specialist.There is not enough evidence to put forth therapeutic recommendations however, treatment decisions can be made on case to case basis after MDT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cells | Experimental | Drug: Mesenchymal stem cells10 patients will be given mesenchymal stem cells at dose 2x10^6 cells/kg MSCs on days 1 and day 7 (if needed) in addition to standard care |
| Placebo | Placebo comparator | Other: PlaceboOnly supportive care will be given to 10 patients |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged ≥ 10years
- Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; and
- Moderate illness: In compliance with the 2019-coronavirus pneumonia diagnosis standard [according to the novel coronavirus infection pneumonia diagnosis and treatment program (Trial Implementation Version 6) issued by the National Health and Medical Commission, and world health organization (WHO) 2019 new coronavirus guidelines standards]: (A) increased breathing rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; (B) in resting state, means oxygen saturation ≤93%; (C) partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa);
- Critically ill : Respiratory failure, Septic Shock, muti-organ dysfunction syndrome (MODS)
Key exclusion criteria (3 listed)
- Patients with systemic autoimmune diseases
- Not consenting for clinical trial
- Those declared not for resuscitation due to underlying comorbid or current critical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stem cellsAlso: MSCs1. Frozen MSCs will be resuspended in 100ml normal saline for immediate use and given intravenously. The patients should be pre-medicated to avoid allergic reactions to third party MSCs. Each patient in Experimental arm will be given 2 x 106 cells/kg will be administered on day 1,7 in addition to supportive care | Drug | Mesenchymal stem cells |
| Placebo100 ml of normal saline will be given intravenously to control arm | Other | Placebo |
Primary outcome
Overall survival
Time frame: 30 days post intervention
Assessment of Overall survival at 30 days post intervention
4 secondary outcomes
Clinical improvement
Time frame: 30 days
Time of COVID19 PCR negativity
Time frame: day 1,3,7,10, 14
Radiological improvement (day 15 and day 30 assessment)
Time frame: day 15 and day30
days required to discharge from hospital
Time frame: 30 days post admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xanab akram study chair
NIBMT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal stem cells in people with COVID-19, run by Dr. Zaineb Akram at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xanab akram (03325346564, xanab.akram@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 30 days post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.