Safety and Biodistribution of an Autologous Bone Marrow-Derived Mononuclear Cell Infusion into Renal Arteries in Patients with Focal Segmental Glomerulosclerosis: A Phase 1 Study
Patients with focal segmental glomerulosclerosis (FSGS) who are refractory to drug treatment may present progressive loss of kidney function, leading to chronic kidney disease stage 5 under dialysis treatment. The safety of systemic administration of bone marrow-derived mononuclear cells (BMDMCs) ha...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-01-01
|
| Series: | Stem Cells International |
| Online Access: | http://dx.doi.org/10.1155/2024/2385568 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832546151717404672 |
|---|---|
| author | Bruno Freire Botelho André Luis Barreira Marcio Gomes Filippo Karina Dutra Asensi Lanuza A P Faccioli Anna Beatriz dos Santos Salgado Elizabeth Figueiredo de Salles Carlos Eduardo Cruz Marques Pedro Leme Silva Regina Coeli dos Santos Goldenberg Angelo Maiolino Bianca Gutfilen Sergio Augusto Lopes de Souza Maurilo Leite Junior Marcelo Marcos Morales |
| author_facet | Bruno Freire Botelho André Luis Barreira Marcio Gomes Filippo Karina Dutra Asensi Lanuza A P Faccioli Anna Beatriz dos Santos Salgado Elizabeth Figueiredo de Salles Carlos Eduardo Cruz Marques Pedro Leme Silva Regina Coeli dos Santos Goldenberg Angelo Maiolino Bianca Gutfilen Sergio Augusto Lopes de Souza Maurilo Leite Junior Marcelo Marcos Morales |
| author_sort | Bruno Freire Botelho |
| collection | DOAJ |
| description | Patients with focal segmental glomerulosclerosis (FSGS) who are refractory to drug treatment may present progressive loss of kidney function, leading to chronic kidney disease stage 5 under dialysis treatment. The safety of systemic administration of bone marrow-derived mononuclear cells (BMDMCs) has been shown in different preclinical models of kidney diseases. However, to date, no study has evaluated the safety and biodistribution of BMDMCs after infusion in renal arteries in patients with FSGS. We used a prospective, non-randomized, single-center longitudinal design to investigate this approach. Five patients with refractory FSGS and an estimated glomerular filtration rate (eGFR) between 20 and 40 ml/min/1.73 m2 underwent bone marrow aspiration and received an arterial infusion of autologous BMDMCs (5 × 107) for each kidney. In addition, BMDMCs labeled with technetium-99m (99mTc-BMDMCs) were used to assess the biodistribution by scintigraphy. All patients completed the 270-day follow-up protocol with no serious adverse events. A transient increase in creatinine was observed after the cell therapy, with improvement on day 30. 99mTc-BMDMCs were detected in both kidneys and counts were higher after 2 hr compared with 24 hr. The arterial infusion of BMDMCs in both kidneys of patients with FSGS was considered safe with stable eGFR at the end of follow-up. This trial is registered with NCT02693366. |
| format | Article |
| id | doaj-art-a9ce41b2d17a4e89952db809806c98d7 |
| institution | Kabale University |
| issn | 1687-9678 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Stem Cells International |
| spelling | doaj-art-a9ce41b2d17a4e89952db809806c98d72025-02-03T07:23:46ZengWileyStem Cells International1687-96782024-01-01202410.1155/2024/2385568Safety and Biodistribution of an Autologous Bone Marrow-Derived Mononuclear Cell Infusion into Renal Arteries in Patients with Focal Segmental Glomerulosclerosis: A Phase 1 StudyBruno Freire Botelho0André Luis Barreira1Marcio Gomes Filippo2Karina Dutra Asensi3Lanuza A P Faccioli4Anna Beatriz dos Santos Salgado5Elizabeth Figueiredo de Salles6Carlos Eduardo Cruz Marques7Pedro Leme Silva8Regina Coeli dos Santos Goldenberg9Angelo Maiolino10Bianca Gutfilen11Sergio Augusto Lopes de Souza12Maurilo Leite Junior13Marcelo Marcos Morales14Department of NephrologyDepartment of NephrologyDepartment of Vascular SurgeryCellular and Molecular Cardiology LaboratoryCellular and Molecular Cardiology LaboratoryCellular and Molecular Cardiology LaboratoryDepartment of RadiologyDepartment of RadiologyLaboratory of Pulmonary InvestigationPrecision Medicine Research CenterDepartment of HematologyDepartment of RadiologyDepartment of RadiologyDepartment of NephrologyLaboratory of Cellular and Molecular PhysiologyPatients with focal segmental glomerulosclerosis (FSGS) who are refractory to drug treatment may present progressive loss of kidney function, leading to chronic kidney disease stage 5 under dialysis treatment. The safety of systemic administration of bone marrow-derived mononuclear cells (BMDMCs) has been shown in different preclinical models of kidney diseases. However, to date, no study has evaluated the safety and biodistribution of BMDMCs after infusion in renal arteries in patients with FSGS. We used a prospective, non-randomized, single-center longitudinal design to investigate this approach. Five patients with refractory FSGS and an estimated glomerular filtration rate (eGFR) between 20 and 40 ml/min/1.73 m2 underwent bone marrow aspiration and received an arterial infusion of autologous BMDMCs (5 × 107) for each kidney. In addition, BMDMCs labeled with technetium-99m (99mTc-BMDMCs) were used to assess the biodistribution by scintigraphy. All patients completed the 270-day follow-up protocol with no serious adverse events. A transient increase in creatinine was observed after the cell therapy, with improvement on day 30. 99mTc-BMDMCs were detected in both kidneys and counts were higher after 2 hr compared with 24 hr. The arterial infusion of BMDMCs in both kidneys of patients with FSGS was considered safe with stable eGFR at the end of follow-up. This trial is registered with NCT02693366.http://dx.doi.org/10.1155/2024/2385568 |
| spellingShingle | Bruno Freire Botelho André Luis Barreira Marcio Gomes Filippo Karina Dutra Asensi Lanuza A P Faccioli Anna Beatriz dos Santos Salgado Elizabeth Figueiredo de Salles Carlos Eduardo Cruz Marques Pedro Leme Silva Regina Coeli dos Santos Goldenberg Angelo Maiolino Bianca Gutfilen Sergio Augusto Lopes de Souza Maurilo Leite Junior Marcelo Marcos Morales Safety and Biodistribution of an Autologous Bone Marrow-Derived Mononuclear Cell Infusion into Renal Arteries in Patients with Focal Segmental Glomerulosclerosis: A Phase 1 Study Stem Cells International |
| title | Safety and Biodistribution of an Autologous Bone Marrow-Derived Mononuclear Cell Infusion into Renal Arteries in Patients with Focal Segmental Glomerulosclerosis: A Phase 1 Study |
| title_full | Safety and Biodistribution of an Autologous Bone Marrow-Derived Mononuclear Cell Infusion into Renal Arteries in Patients with Focal Segmental Glomerulosclerosis: A Phase 1 Study |
| title_fullStr | Safety and Biodistribution of an Autologous Bone Marrow-Derived Mononuclear Cell Infusion into Renal Arteries in Patients with Focal Segmental Glomerulosclerosis: A Phase 1 Study |
| title_full_unstemmed | Safety and Biodistribution of an Autologous Bone Marrow-Derived Mononuclear Cell Infusion into Renal Arteries in Patients with Focal Segmental Glomerulosclerosis: A Phase 1 Study |
| title_short | Safety and Biodistribution of an Autologous Bone Marrow-Derived Mononuclear Cell Infusion into Renal Arteries in Patients with Focal Segmental Glomerulosclerosis: A Phase 1 Study |
| title_sort | safety and biodistribution of an autologous bone marrow derived mononuclear cell infusion into renal arteries in patients with focal segmental glomerulosclerosis a phase 1 study |
| url | http://dx.doi.org/10.1155/2024/2385568 |
| work_keys_str_mv | AT brunofreirebotelho safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT andreluisbarreira safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT marciogomesfilippo safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT karinadutraasensi safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT lanuzaapfaccioli safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT annabeatrizdossantossalgado safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT elizabethfigueiredodesalles safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT carloseduardocruzmarques safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT pedrolemesilva safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT reginacoelidossantosgoldenberg safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT angelomaiolino safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT biancagutfilen safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT sergioaugustolopesdesouza safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT mauriloleitejunior safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study AT marcelomarcosmorales safetyandbiodistributionofanautologousbonemarrowderivedmononuclearcellinfusionintorenalarteriesinpatientswithfocalsegmentalglomerulosclerosisaphase1study |