Treatment of Long COVID Symptoms Utilizing Autologous Stem Cells Following COVID-19 Infection
NCT05669261 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-06-09
Summary
The project is described as a Phase 1 Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and secondarily to be vigilant for signals of amelioration of symptoms associated with Post-Acute Sequelae of SARS-CoV-2 infection
Conditions
Interventions
- PROCEDURE
-
Adipose Tissue Harvest
Local Anesthesia will be administered. A Stab wound will be created at the harvest site through which a 3.0 or 2.5 mm cannula will be inserted to suction fat using the "syringe" (i.e. manual) technique. A total of 100 cc of lipoaspirate will be collected by manual draw of the adipose tissue into syringes.
- BIOLOGICAL
-
ATCell
Infusion of the study medication at the rate of 575 mL/HR (500ml of LRD5 plus 75ml of ATCell suspended in LRD5) and continue until all received trial medication has been delivered.
Sponsors & Collaborators
-
American CryoStem Corporation
lead INDUSTRY
Principal Investigators
-
Anthony Y Dudzinski · American CryoStem Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-01
- Primary Completion
- 2023-12-31
- Completion
- 2024-02-01
- FDA Drug
- Yes
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