Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-05-05
Study Completion Date
2024-03-01
Brief Summary
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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.
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.
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Detailed Description
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The recent outbreak of Coronavirus 2 (SARS-CoV-2) has spread rapidly throughout the world, resulting in a global pandemic with devastating socioeconomic consequences. After being declared a public health emergency by the World Health Organization (WHO), there is an urgent need to develop effective therapeutic strategies for critically ill COVID-19 patients. This new virus strain causes a complex disease with a wide range of presentations, from mild symptoms to multi-organ failure. A common feature of severe cases is the pathologically complex "cytokine storm" that presents as an excessive immune response with rapid progression of disease and high mortality. In particular, the severe outcomes of SARS CoV-2 are associated with elevated C-reactive protein and Interleukin-6 in the lungs. COVID-19 infection can rapidly decompensate into severe respiratory failure requiring intubation and mechanical ventilation. The need for mechanical ventilation portends a poor prognosis, with a reported mortality rate of up to 88%.
Survivors of COVID-19 pneumonia face sequelae of their disease that affect multiple organ systems. In particular, a significant number present with ongoing problems of breathlessness and reduced oxygenation, turning previously healthy patients into virus-induced pulmonary cripples. The mechanism for this is the intense scarring and destruction of the microcirculation found in the lungs of COVID-19 survivors. There is an urgent need for the development of treatment protocols that are capable of reducing the degree of pulmonary fibrosis and promoting local angiogenesis to better support injured alveoli.
In recent decades, mesenchymal stromal cells (MSCs) have emerged as a potential therapeutic agent for cell-based therapies due to the beneficial effects on immunomodulation and tissue repair/regeneration. These cells possess properties unique self-renewal and capacity to differentiate into multiple lineages. MSCs are found in small numbers in bone marrow (BMSC) and umbilical cord tissue. MSCs are also found in adipose tissue (referred to as ASCs) where they exist as part of a multicellular population, the stromal vascular fraction (SVF). ASC populations are 500-1000 more abundant than their bone marrow counterparts.
Adipose tissue provides a source of Stromal Vascular Fraction (SVF) that can be isolated and transplanted to the patient during the same surgical procedure, at the point of care. SVF is a heterogeneous mixture of stromal progenitor cells, pericytes, endothelial precursor cells, and macrophages. Acting collectively, SVF has been shown to possess broad anti-inflammatory and regenerative properties. SVF has been shown to be safe after IV administration and has shown some promising results in restoring respiratory function in patients with severe lung disorders. Based on public analysis of single cell RNA sequencing (scRNA-seq) data, SVF demonstrates the absence of ACE2 expression, indicating its potential as a resistant phenotype to SARS-CoV-2 infection. In Taken together, IV administration of adipose- derived SVF is presented as a novel treatment approach to improve the clinical outcome of respiratory-compromised COVID-19 patients.
The clinical impact of SVF for COVID-19 is based on 5 mechanisms of action. These have been widely documented (see attached publications and bibliography).
Anti-inflammatory Immunomodulation, especially T-regs Antifibrosis. Matrix metalloproteinases and liver growth factor. Support for regenerative cell populations in situ. Lung asthma studies Angiogenesis under ischemic conditions, based on the release of VEGF.
Therapy with SVF cells from adipose tissue is advantageous as large numbers of cells can be removed from small volumes (30-90 cc) by a minimally invasive liposuction procedure.
Indication for expanded access
This is an expanded access study to treat a small group of subjects with pulmonary sequelae after recovery from COVID-19 pneumonia of autologous adipose-derived SVF administered using as single intravenous injection.
Objectives of clinical research
Main objective
To assess the safety of a single injection of autologous adipose-derived SVF produced with the GID SVF-2 device for the treatment of respiratory distress.
associated with COVID-19.
Secondary objective
To assess efficacy, by (1) maintaining SaO2 saturation ≥ at the existing level on noninvasive oxygen support, (2) achieving a reduction in the level of oxygen support required to maintain SaO2 ≥ 92, using intravenous injection of autologous adipose derived SVF produced using the GID SVF-2 device system for the treatment of respiratory distress associated with COVID-19.
Expected duration of the clinical investigation
Follow-up controls at 3, 6, 9, and 12 months. The total duration of the study is 1 year.
Clinical Protocol
Study design
General study design
This is a prospective, multicenter, expanded access interventional study of subjects with COVID-19. Forty (40) subjects with confirmed COVID-19 and SaO2 ≤ 92 were treated. Subjects received an intravenous injection of autologous adipose-derived SVF. Subjects will be followed for 6 weeks.
Study procedures
Detection procedures
The initial evaluation was done at the local Centro de Salud. Subjects were then referred to HEODRA or HECAM for confirmatory diagnosis and additional tests.
Concomitant medications
All concomitant medications considered Standard of Care are accepted. A concomitant medication case report form will be completed at each subject follow-up visit.
Summary of study treatment
40 non-randomized patients will be treated with autologous SVF. Minimum dosage: 45x106 ± 5x106 cells Treatment plan: a single intervention
Follow-up Serum samples (20 cc) - inflammation factors: 1 month, 3 months, 6 months PFTs + DLco: preop, 1 month, 3 months, 6 months weeks, and 12 months CT: preop, 3 months, 6 months, 12 months SF-36 quality of life questionnaire SF-36 (Medical Outcomes Trust): pre-op, 12 months SGRQ-C respiratory questionnaire SGRQ-C (St. George's University): pre-op, 12 months
The subject's adipose tissue will be acquired by liposuction of the abdomen or flanks and placed directly into the GID SVF-2 device. The harvested adipose tissue will be enzymatically digested in the same GID SVF-2 device using the GIDZyme-2-70 enzyme and centrifuged in the same GID SVF-2 device to concentrate the SVF cells. SVF cells will be removed and an active treatment dose of 45 x 106 (±5 x 106) SVF cells will be injected into a 100 ml IV bag containing LR. Fluids will be given through an IV catheter through a blood filter over 10 minutes.
Dosage
Dose preparation
Using the LunaStem® Nucleocounter Cell Concentration and Dilution Factor 100 calculate the volume needed using the following equation and transfer that amount of resuspension to a 10 mL syringe.
#ml = dose = 40 x 106 (+/- 5x106)
Dose administration The way to administer SVF for vascular use is the same whether it is intravenous (IV) or intravenous (IA).
The treatment was administered intravenously using an intravenous catheter with a blood filter.
Add the dose to a 100 ml bag of LR that has been warmed to 37°C and mix well. Administer the 100 ml over 10 minutes.
Adherence to treatment
Each subject had time to read the consent form and ask questions about the study before signing the informed consent. Subjects should contact the physician or staff if participant have any concerns during the study. It will be emphasized that the subject must comply with the protocol and be honest about her symptoms.
Withdrawal of subjects for non-compliance
Subjects may be terminated from the study at the discretion of the principal investigator only for reasons related to study examinations that would jeopardize the subject's health and/or welfare if participants were to continue in the study. Subjects may voluntarily withdraw from the study at any time without prejudice.
• Subjects withdrawn will not be replaced if participant have received study treatment.
Schedule of study visits
The initial evaluation and informed consent took place in the hospitals. Prior to treatment, subjects were evaluated to determine if participant meet the inclusion/exclusion criteria. If not already provided, demographics, medical history, concomitant medications, SaO2, and arterial blood gases was collected. The subject were enrolled if participant meet all the eligibility criteria and have signed the Informed Consent.
The time between enrollment and treatment not exceeded 48 hours.
On the day of treatment, each subject was reassessed for inclusion in the study.
Survivors of COVID-19 pneumonia face sequelae of their disease that affect multiple organ systems. In particular, a significant number present with ongoing problems of breathlessness and reduced oxygenation, turning previously healthy patients into virus-induced pulmonary cripples. The mechanism for this is the intense scarring and destruction of the microcirculation found in the lungs of COVID-19 survivors. There is an urgent need for the development of treatment protocols that are capable of reducing the degree of pulmonary fibrosis and promoting local angiogenesis to better support injured alveoli.
In recent decades, mesenchymal stromal cells (MSCs) have emerged as a potential therapeutic agent for cell-based therapies due to the beneficial effects on immunomodulation and tissue repair/regeneration. These cells possess properties unique self-renewal and capacity to differentiate into multiple lineages. MSCs are found in small numbers in bone marrow (BMSC) and umbilical cord tissue. MSCs are also found in adipose tissue (referred to as ASCs) where they exist as part of a multicellular population, the stromal vascular fraction (SVF). ASC populations are 500-1000 more abundant than their bone marrow counterparts.
Adipose tissue provides a source of Stromal Vascular Fraction (SVF) that can be isolated and transplanted to the patient during the same surgical procedure, at the point of care. SVF is a heterogeneous mixture of stromal progenitor cells, pericytes, endothelial precursor cells, and macrophages. Acting collectively, SVF has been shown to possess broad anti-inflammatory and regenerative properties. SVF has been shown to be safe after IV administration and has shown some promising results in restoring respiratory function in patients with severe lung disorders. Based on public analysis of single cell RNA sequencing (scRNA-seq) data, SVF demonstrates the absence of ACE2 expression, indicating its potential as a resistant phenotype to SARS-CoV-2 infection. In Taken together, IV administration of adipose- derived SVF is presented as a novel treatment approach to improve the clinical outcome of respiratory-compromised COVID-19 patients.
The clinical impact of SVF for COVID-19 is based on 5 mechanisms of action. These have been widely documented (see attached publications and bibliography).
Anti-inflammatory Immunomodulation, especially T-regs Antifibrosis. Matrix metalloproteinases and liver growth factor. Support for regenerative cell populations in situ. Lung asthma studies Angiogenesis under ischemic conditions, based on the release of VEGF.
Therapy with SVF cells from adipose tissue is advantageous as large numbers of cells can be removed from small volumes (30-90 cc) by a minimally invasive liposuction procedure.
Indication for expanded access
This is an expanded access study to treat a small group of subjects with pulmonary sequelae after recovery from COVID-19 pneumonia of autologous adipose-derived SVF administered using as single intravenous injection.
Objectives of clinical research
Main objective
To assess the safety of a single injection of autologous adipose-derived SVF produced with the GID SVF-2 device for the treatment of respiratory distress.
associated with COVID-19.
Secondary objective
To assess efficacy, by (1) maintaining SaO2 saturation ≥ at the existing level on noninvasive oxygen support, (2) achieving a reduction in the level of oxygen support required to maintain SaO2 ≥ 92, using intravenous injection of autologous adipose derived SVF produced using the GID SVF-2 device system for the treatment of respiratory distress associated with COVID-19.
Expected duration of the clinical investigation
Follow-up controls at 3, 6, 9, and 12 months. The total duration of the study is 1 year.
Clinical Protocol
Study design
General study design
This is a prospective, multicenter, expanded access interventional study of subjects with COVID-19. Forty (40) subjects with confirmed COVID-19 and SaO2 ≤ 92 were treated. Subjects received an intravenous injection of autologous adipose-derived SVF. Subjects will be followed for 6 weeks.
Study procedures
Detection procedures
The initial evaluation was done at the local Centro de Salud. Subjects were then referred to HEODRA or HECAM for confirmatory diagnosis and additional tests.
Concomitant medications
All concomitant medications considered Standard of Care are accepted. A concomitant medication case report form will be completed at each subject follow-up visit.
Summary of study treatment
40 non-randomized patients will be treated with autologous SVF. Minimum dosage: 45x106 ± 5x106 cells Treatment plan: a single intervention
Follow-up Serum samples (20 cc) - inflammation factors: 1 month, 3 months, 6 months PFTs + DLco: preop, 1 month, 3 months, 6 months weeks, and 12 months CT: preop, 3 months, 6 months, 12 months SF-36 quality of life questionnaire SF-36 (Medical Outcomes Trust): pre-op, 12 months SGRQ-C respiratory questionnaire SGRQ-C (St. George's University): pre-op, 12 months
The subject's adipose tissue will be acquired by liposuction of the abdomen or flanks and placed directly into the GID SVF-2 device. The harvested adipose tissue will be enzymatically digested in the same GID SVF-2 device using the GIDZyme-2-70 enzyme and centrifuged in the same GID SVF-2 device to concentrate the SVF cells. SVF cells will be removed and an active treatment dose of 45 x 106 (±5 x 106) SVF cells will be injected into a 100 ml IV bag containing LR. Fluids will be given through an IV catheter through a blood filter over 10 minutes.
Dosage
Dose preparation
Using the LunaStem® Nucleocounter Cell Concentration and Dilution Factor 100 calculate the volume needed using the following equation and transfer that amount of resuspension to a 10 mL syringe.
#ml = dose = 40 x 106 (+/- 5x106)
Dose administration The way to administer SVF for vascular use is the same whether it is intravenous (IV) or intravenous (IA).
The treatment was administered intravenously using an intravenous catheter with a blood filter.
Add the dose to a 100 ml bag of LR that has been warmed to 37°C and mix well. Administer the 100 ml over 10 minutes.
Adherence to treatment
Each subject had time to read the consent form and ask questions about the study before signing the informed consent. Subjects should contact the physician or staff if participant have any concerns during the study. It will be emphasized that the subject must comply with the protocol and be honest about her symptoms.
Withdrawal of subjects for non-compliance
Subjects may be terminated from the study at the discretion of the principal investigator only for reasons related to study examinations that would jeopardize the subject's health and/or welfare if participants were to continue in the study. Subjects may voluntarily withdraw from the study at any time without prejudice.
• Subjects withdrawn will not be replaced if participant have received study treatment.
Schedule of study visits
The initial evaluation and informed consent took place in the hospitals. Prior to treatment, subjects were evaluated to determine if participant meet the inclusion/exclusion criteria. If not already provided, demographics, medical history, concomitant medications, SaO2, and arterial blood gases was collected. The subject were enrolled if participant meet all the eligibility criteria and have signed the Informed Consent.
The time between enrollment and treatment not exceeded 48 hours.
On the day of treatment, each subject was reassessed for inclusion in the study.
Conditions
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Pulmonary Fibrosis
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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SVF cells treatment
40 subjects were treated with autologous SVF intravenous treatment.
Group Type
EXPERIMENTAL
Autologous adipose-derived SVF IV administration
Intervention Type
BIOLOGICAL
Subjects received an intravenous injection of autologous adipose-derived SVF.
Interventions
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Autologous adipose-derived SVF IV administration
Subjects received an intravenous injection of autologous adipose-derived SVF.
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
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.
* 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.
Exclusion Criteria
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ministerio de Salud de Nicaragua
UNKNOWN
Sponsor Role
collaborator
Wake Forest University
OTHER
Sponsor Role
collaborator
National Autonomous University of Nicaragua
OTHER
Sponsor Role
collaborator
Michael H Carstens
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Carlos Lopez, MD
Role: STUDY_DIRECTOR
Hospital Escuela Oscar Danilo Rosales, Leon (HEODRA)
Yanury Dolmus, MD
Role: STUDY_DIRECTOR
Hospital Escuela Cesar Amador Molina, Matagalpa (HECAM)
Locations
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Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA)
León, León Department, Nicaragua
Site Status
Hospital Escuela Cesar Amador Molina
Matagalpa, , Nicaragua
Site Status
Countries
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Nicaragua
References
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Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.
Reference Type
BACKGROUND
WHO Director-General's opening remarks at the media briefing on COVID-19 - 11 March2020. https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the- media-briefing-on-covid-19---11-march-2020. Published 2020
Reference Type
BACKGROUND
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Reference Type
BACKGROUND
Jiang S, Du L, Shi Z. An emerging coronavirus causing pneumonia outbreak in Wuhan, China: calling for developing therapeutic and prophylactic strategies. Emerg Microbes Infect. 2020 Jan 31;9(1):275-277. doi: 10.1080/22221751.2020.1723441. eCollection 2020. No abstract available.
Reference Type
BACKGROUND
Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
Reference Type
BACKGROUND
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
Reference Type
BACKGROUND
Weiss P, Murdoch DR. Clinical course and mortality risk of severe COVID-19. Lancet. 2020 Mar 28;395(10229):1014-1015. doi: 10.1016/S0140-6736(20)30633-4. Epub 2020 Mar 17. No abstract available.
Reference Type
BACKGROUND
Pittenger MF, Discher DE, Peault BM, Phinney DG, Hare JM, Caplan AI. Mesenchymal stem cell perspective: cell biology to clinical progress. NPJ Regen Med. 2019 Dec 2;4:22. doi: 10.1038/s41536-019-0083-6. eCollection 2019.
Reference Type
BACKGROUND
Nauta AJ, Fibbe WE. Immunomodulatory properties of mesenchymal stromal cells. Blood. 2007 Nov 15;110(10):3499-506. doi: 10.1182/blood-2007-02-069716. Epub 2007 Jul 30.
Reference Type
BACKGROUND
Le Blanc K, Davies LC. Mesenchymal stromal cells and the innate immune response. Immunol Lett. 2015 Dec;168(2):140-6. doi: 10.1016/j.imlet.2015.05.004. Epub 2015 May 15.
Reference Type
BACKGROUND
Chamberlain G, Fox J, Ashton B, Middleton J. Concise review: mesenchymal stem cells: their phenotype, differentiation capacity, immunological features, and potential for homing. Stem Cells. 2007 Nov;25(11):2739-49. doi: 10.1634/stemcells.2007-0197. Epub 2007 Jul 26.
Reference Type
BACKGROUND
Nguyen A, Guo J, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 1: Current concepts and review of the literature. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):170-9. doi: 10.1016/j.bjps.2015.10.015. Epub 2015 Oct 31.
Reference Type
BACKGROUND
Brown, P, Katz AJ. Adipose -derived stem cells In: Atala A (ed). Textbook of Regenerative Medicine Elsevier, 3rd ed. 2019, pp.
Reference Type
BACKGROUND
Kapur SK, Dos-Anjos Vilaboa S, Llull R, Katz AJ. Adipose tissue and stem/progenitor cells: discovery and development. Clin Plast Surg. 2015 Apr;42(2):155-67. doi: 10.1016/j.cps.2014.12.010.
Reference Type
BACKGROUND
Guo J, Nguyen A, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 2: Mechanisms of regenerative action. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):180-8. doi: 10.1016/j.bjps.2015.10.014. Epub 2015 Oct 24.
Reference Type
BACKGROUND
Regmi S, Pathak S, Kim JO, Yong CS, Jeong JH. Mesenchymal stem cell therapy for the treatment of inflammatory diseases: Challenges, opportunities, and future perspectives. Eur J Cell Biol. 2019 Dec;98(5-8):151041. doi: 10.1016/j.ejcb.2019.04.002. Epub 2019 Apr 14.
Reference Type
BACKGROUND
Limper AH. Safety of IV Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis. Chest. 2017 May;151(5):951-952. doi: 10.1016/j.chest.2016.12.015. No abstract available.
Reference Type
BACKGROUND
Comella K, Blas JAP, Ichim T, Lopez J, Limon J, Moreno RC. Autologous Stromal Vascular Fraction in the Intravenous Treatment of End-Stage Chronic Obstructive Pulmonary Disease: A Phase I Trial of Safety and Tolerability. J Clin Med Res. 2017 Aug;9(8):701-708. doi: 10.14740/jocmr3072w. Epub 2017 Jul 1.
Reference Type
BACKGROUND
Michalek J, Vrablikova A, Heinrich KG, Dudasova Z. Stromal Vascular Fraction Cell Therapy for a Stroke Patient-Cure without Side Effects. Brain Sci. 2019 Mar 6;9(3):55. doi: 10.3390/brainsci9030055.
Reference Type
BACKGROUND
Turner AJ, Hiscox JA, Hooper NM. ACE2: from vasopeptidase to SARS virus receptor. Trends Pharmacol Sci. 2004 Jun;25(6):291-4. doi: 10.1016/j.tips.2004.04.001.
Reference Type
BACKGROUND
Leng Z, Zhu R, Hou W, Feng Y, Yang Y, Han Q, Shan G, Meng F, Du D, Wang S, Fan J, Wang W, Deng L, Shi H, Li H, Hu Z, Zhang F, Gao J, Liu H, Li X, Zhao Y, Yin K, He X, Gao Z, Wang Y, Yang B, Jin R, Stambler I, Lim LW, Su H, Moskalev A, Cano A, Chakrabarti S, Min KJ, Ellison-Hughes G, Caruso C, Jin K, Zhao RC. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia. Aging Dis. 2020 Mar 9;11(2):216-228. doi: 10.14336/AD.2020.0228. eCollection 2020 Apr.
Reference Type
BACKGROUND
Caplan AI, Correa D. The MSC: an injury drugstore. Cell Stem Cell. 2011 Jul 8;9(1):11-5. doi: 10.1016/j.stem.2011.06.008.
Reference Type
BACKGROUND
Gutta S, Grobe N, Kumbaji M, Osman H, Saklayen M, Li G, Elased KM. Increased urinary angiotensin converting enzyme 2 and neprilysin in patients with type 2 diabetes. Am J Physiol Renal Physiol. 2018 Aug 1;315(2):F263-F274. doi: 10.1152/ajprenal.00565.2017. Epub 2018 Mar 21.
Reference Type
BACKGROUND
Giannandrea M, Parks WC. Diverse functions of matrix metalloproteinases during fibrosis. Dis Model Mech. 2014 Feb;7(2):193-203. doi: 10.1242/dmm.012062.
Reference Type
BACKGROUND
Pardo A, Cabrera S, Maldonado M, Selman M. Role of matrix metalloproteinases in the pathogenesis of idiopathic pulmonary fibrosis. Respir Res. 2016 Mar 4;17:23. doi: 10.1186/s12931-016-0343-6.
Reference Type
BACKGROUND
Crestani B, Marchand-Adam S, Quesnel C, Plantier L, Borensztajn K, Marchal J, Mailleux A, Soler P, Dehoux M. Hepatocyte growth factor and lung fibrosis. Proc Am Thorac Soc. 2012 Jul;9(3):158-63. doi: 10.1513/pats.201202-018AW.
Reference Type
BACKGROUND
Castro LL, Kitoko JZ, Xisto DG, Olsen PC, Guedes HLM, Morales MM, Lopes-Pacheco M, Cruz FF, Rocco PRM. Multiple doses of adipose tissue-derived mesenchymal stromal cells induce immunosuppression in experimental asthma. Stem Cells Transl Med. 2020 Feb;9(2):250-260. doi: 10.1002/sctm.19-0120. Epub 2019 Nov 20.
Reference Type
BACKGROUND
Zakhari JS, Zabonick J, Gettler B, Williams SK. Vasculogenic and angiogenic potential of adipose stromal vascular fraction cell populations in vitro. In Vitro Cell Dev Biol Anim. 2018 Jan;54(1):32-40. doi: 10.1007/s11626-017-0213-7. Epub 2017 Dec 1.
Reference Type
BACKGROUND
Carstens MH, Gomez A, Cortes R, Turner E, Perez C, Ocon M, Correa D. Non-reconstructable peripheral vascular disease of the lower extremity in ten patients treated with adipose-derived stromal vascular fraction cells. Stem Cell Res. 2017 Jan;18:14-21. doi: 10.1016/j.scr.2016.12.001. Epub 2016 Dec 8.
Reference Type
BACKGROUND
Other Identifiers
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CIRE.112
Identifier Type: -
Identifier Source: org_study_id
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PHASE1
Study of F-652 in Subjects With Corona Virus Disease 2019 (COVID-19) Pneumonia
NCT05205668
WITHDRAWN
PHASE2
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
NCT07048262
RECRUITING
PHASE2
Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis
NCT03903913
UNKNOWN
PHASE2
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
NCT03573505
TERMINATED
PHASE2
A Clinical Study of Mesenchymal Progenitor Cell Exosomes Nebulizer for the Treatment of Pulmonary Infection
NCT04544215
SUSPENDED
PHASE1/PHASE2
Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
NCT01559051
WITHDRAWN
PHASE1/PHASE2
JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
NCT03538301
COMPLETED
PHASE2
A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment
NCT07036523
RECRUITING
PHASE2
Effects of Bronchial Segmental Endotoxin Instillation in Humans
NCT02392442
ENROLLING_BY_INVITATION
PHASE2
Comparison Between Different Ways for Using Lidocaine During FB
NCT06563050
NOT_YET_RECRUITING
NA
A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
NCT01203943
TERMINATED
PHASE2
A Study to Evaluate Safety and Efficacy of BOTOX in Adults With Moderate COPD
NCT06003049
COMPLETED
PHASE2
Menstrual Blood-Derived Mesenchymal Stem Cell Injection (SC01009) in the Treatment of Idiopathic Pulmonary Fibrosis
NCT07131150
NOT_YET_RECRUITING
PHASE2
A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SM04646 Inhalation Solution in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
NCT03591926
WITHDRAWN
PHASE2
Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis
NCT05674994
RECRUITING
PHASE3
To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)
NCT01529853
COMPLETED
PHASE1/PHASE2
Evaluate the Efficacy and Safety of TF0023 in Treatments for COVID-19 in Hospitalized Adults
NCT05212818
TERMINATED
PHASE2
Comparison of Time to Extubation Using Sugammadex or Neostigmine
NCT04606901
COMPLETED
PHASE4
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Exosomes in Treating Chronic Cough After COVID-19
NCT05808400
UNKNOWN
EARLY_PHASE1
The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2
NCT04313023
COMPLETED
PHASE2
Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis
NCT06589219
RECRUITING
PHASE1
A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis
NCT00563212
COMPLETED
PHASE1