Status:
COMPLETED
Efficacy of Intravenous Infusions of Stem Cells in the Treatment of COVID-19 Patients
Lead Sponsor:
Jinnah Hospital
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Corona Virus Infection
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
Brief Summary
Stem cell therapy has emerged as a revolutionary treatment for diseases that were considered untreatable only a few years ago. Umbilical cord-derived mesenchymal stem cells (UCMSCs) have been shown to...
Detailed Description
Isolation and characterization of human umbilical cord-derived mesenchymal stem cells (UCMSCs): Human umbilical cord tissues along with informed consent forms will be collected from hepatitis B, C, an...
Eligibility Criteria
Inclusion
- Provide written informed consent
- Male or female subjects age \>18 years at the time of signing the Informed Consent Form
- Must have a clinical diagnosis of COVID-19, with at least one of clinical symptoms (e.g., fever ≥38°C, fatigue, cough) and a positive result by the reverse-transcription polymerase chain reaction (RT-PCR) testing or equivalent
- Individuals with moderate to severe COVID-19 symptoms
- Adequate venous access
- For female patients only, willingness to use recommended birth control until 6 months post-treatment
- Must agree to comply with all study requirements and be willing to complete all study visits
- Need in-patient admission
Exclusion
- A female who is pregnant, nursing, or of child-bearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening and prior to infusion.
- Inability to perform any of the assessments required for endpoint analysis
- Have known allergies to penicillin or streptomycin
- Have a clinical history of malignancy within 3 years (i.e., subjects with prior malignancy must be disease-free for 3 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma, if recurrence occurs; - History of drug abuse (illegal "street" drugs except for marijuana, or prescription medications not being used appropriately for a pre-existing medical condition) or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months
- Be serum positive for HIV, hepatitis BsAg or Viremic hepatitis C.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04437823
Start Date
June 1 2020
End Date
November 30 2021
Last Update
October 17 2023
Active Locations (1)
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1
Jinnah Hospital
Lahore, Punjab Province, Pakistan, 54550