SVF for Treating Pulmonary Fibrosis Post COVID-19

NCT06304623 | Completed Phase 1

• 1 other identifier: CIRE.112
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

General description of the study This is a prospective, multicenter, expanded access interventional study of subjects recovered from COVID-19 pneumonia to assess their response to intravenous administration of adipose-derived autologous SVF. Primary objective The purpose of this study was to evaluate the safety of single intravenous injections of autologous adipose-derived SVF produced using the GID SVF-2 device system for the treatment of secondary respiratory distress associated with COVID-19. Secondary objective To evaluate the efficacy of the initial treatment with SVF IV.

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Safety of treatment with SVF IV

  None of the participants with potential pulmonary severe adverse events (SAE) related to the SVF cell infusion of single intravenous injection of autologous adipose-derived SVF produced using the GID SVF-2 device system.

  Up to 12 months post injection.

Secondary Outcomes (1)

• Efficacy of the initial treatment with SVF IV

  Up to 12 months

Other Outcomes (1)

• Effectiveness of the initial treatment with SVF IV

  Up to 12 months

Study Arms (1)

SVF cells treatment

EXPERIMENTAL

40 subjects were treated with autologous SVF intravenous treatment.

Biological: Autologous adipose-derived SVF IV administration

Interventions

Autologous adipose-derived SVF IV administration BIOLOGICAL

Subjects received an intravenous injection of autologous adipose-derived SVF.

SVF cells treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were identified at Managua and Leon, Nicaragua, community health centers and screened for eligibility by study physicians.
• Forty PCR-confirmed COVID-19 patients
• Persistent pulmonary complaints of dyspnea for at least 2 months after hospital discharge.
• Age 18 - 85 years.
• Male or Female.
• A body mass index of \> 22.
• Forced vital capacity (FVC) \> 40% predicted and \< 70% predicted
• Diffusing lung capacity of the lungs for carbon monoxide (DLCO) \> 20% predicted and \< 70% predicted.

You may not qualify if:

• Use of home oxygen
• History of pulmonary malignancy.
• Immunosuppressive drug treatment
• History of prior cardiac disease with an ejection fraction of ≤30%
• Diabetes
• Pregnancy or plans to conceive during the study period.
• Participation in another clinical study.

Sponsors & Collaborators

• Michael H Carstens: lead
• Ministerio de Salud de Nicaragua: collaborator
• Wake Forest University: collaborator
• National Autonomous University of Nicaragua: collaborator

Study Sites (2)

Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA)

León, León Department, 21000, Nicaragua

Location

Hospital Escuela Cesar Amador Molina

Matagalpa, 61000, Nicaragua

Location

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MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos Lopez, MD

  Hospital Escuela Oscar Danilo Rosales, Leon (HEODRA)

  STUDY DIRECTOR

• Yanury Dolmus, MD

  Hospital Escuela Cesar Amador Molina, Matagalpa (HECAM)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: May 5, 2020
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

NI (2)