Back to results

A Study of Cell Therapy for Subjects With Acute Kidney Injury Who Are Receiving Continuous Renal Replacement Therapy

Primary Purpose

Acute Kidney Injury

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SBI-101

Sham

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Mesenchymal stromal cells, MSC, Stem cells, Mesenchymal stem cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

AKI, as determined by the Investigator based on his/her clinical judgment
Able to tolerate indwelling intravascular access
Has tolerated Continuous Renal Replacement Therapy for at least 12 hours prior to IP treatment
Likely to require Continuous Renal Replacement Therapy for at least an additional 48 hours
Ability to give informed consent

Exclusion Criteria:

Female subjects who are pregnant, planning to become pregnant, or lactating
Known end-stage liver disease
Hepatorenal syndrome
Acute glomerulonephritis (e.g. rapidly progressive glomerulonephritis; membranoproliferative glomerulonephritis; post-streptococcal glomerulonephritis); acute interstitial nephritis (e.g. toxin- or drug- induced interstitial nephritis) or hereditary renal disease (e.g. Alport's Syndrome; polycystic kidney disease)
AKI due to post-renal outflow obstruction
Acute or chronic vasculitis of any etiology
At the time of randomization, clinical evidence (e.g. febrile) suggestive of an uncontrolled or inadequately treated systemic infection
History of a chronic systemic infection of any etiology regardless of therapy
Active malignancy(-ies) and/or receiving active treatment for a malignancy(-ies), with the exception of non-melanoma skin cancer
Subjects, who in the opinion of the Investigator, are likely to require escalating doses of vasopressors to attain and/or maintain hemodynamic stability
Systemic immunosuppressive therapy that has not been stabilized for greater than 4 months, or in the case of chronic corticosteroid therapy, a dose of >15 mg/day of prednisone or the equivalent within the past 30 days
Organ failure affecting more than 2 non-renal organs
Platelet count <25,000/uL or other serious hematological abnormalities that would place subject in imminent danger of death
Any prior medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements

Sites / Locations

Lehigh Valley Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Arm Label

Low dose cohort

High dose cohort

Control

Arm Description

SBI-101 device containing 250 million MSCs

SBI-101 device containing 750 million MSCs

Sham device containing no MSCs

Outcomes

Primary Outcome Measures

Safety and tolerability as measured by incidence of IP-related serious adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT03015623

First Posted

January 6, 2017

Last Updated

March 15, 2021

Sponsor

Sentien Biotechnologies, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03015623

Brief Title

A Study of Cell Therapy for Subjects With Acute Kidney Injury Who Are Receiving Continuous Renal Replacement Therapy

Official Title

A Multi-center, Randomized, Sham-controlled, Double-blind, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 Therapy) in Subjects With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 20, 2017 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sentien Biotechnologies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with Acute Kidney Injury (AKI) who require continuous renal replacement therapy. SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. The study will be conducted in two cohorts, with an interim analysis performed in between the cohorts. In the first cohort, subjects will be randomized to receive one of two treatments - low dose SBI-101 or sham control. In the second cohort, subjects will be randomized to receive one of two treatments - high dose SBI-101 or sham control. SBI-101 or sham control will be integrated into the renal replacement circuit and subjects in both cohorts will be treated for up to 24 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

Keywords

Mesenchymal stromal cells, MSC, Stem cells, Mesenchymal stem cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low dose cohort

Arm Type

Experimental

Arm Description

SBI-101 device containing 250 million MSCs

Arm Title

High dose cohort

Arm Type

Experimental

Arm Description

SBI-101 device containing 750 million MSCs

Arm Title

Control

Arm Type

Sham Comparator

Arm Description

Sham device containing no MSCs

Intervention Type

Biological

Intervention Name(s)

SBI-101

Intervention Description

SBI-101 is a biologic/device combination product that combines two components: allogeneic human mesenchymal stromal cells (MSCs) and an FDA-approved plasmapheresis device. SBI-101 is administered via integration into a Continuous Renal Replacement Therapy circuit and is designed to regulate inflammation and promote repair of injured tissue.

Intervention Type

Device

Intervention Name(s)

Sham

Intervention Description

The sham control is an FDA-approved plasmapheresis device, without MSCs, which is integrated into a Continuous Renal Replacement Therapy circuit.

Primary Outcome Measure Information:

Title

Safety and tolerability as measured by incidence of IP-related serious adverse events

Time Frame

Outcomes out to Day 28 and Serious Adverse Events through Day 180

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: AKI, as determined by the Investigator based on his/her clinical judgment Able to tolerate indwelling intravascular access Has tolerated Continuous Renal Replacement Therapy for at least 12 hours prior to IP treatment Likely to require Continuous Renal Replacement Therapy for at least an additional 48 hours Ability to give informed consent Exclusion Criteria: Female subjects who are pregnant, planning to become pregnant, or lactating Known end-stage liver disease Hepatorenal syndrome Acute glomerulonephritis (e.g. rapidly progressive glomerulonephritis; membranoproliferative glomerulonephritis; post-streptococcal glomerulonephritis); acute interstitial nephritis (e.g. toxin- or drug- induced interstitial nephritis) or hereditary renal disease (e.g. Alport's Syndrome; polycystic kidney disease) AKI due to post-renal outflow obstruction Acute or chronic vasculitis of any etiology At the time of randomization, clinical evidence (e.g. febrile) suggestive of an uncontrolled or inadequately treated systemic infection History of a chronic systemic infection of any etiology regardless of therapy Active malignancy(-ies) and/or receiving active treatment for a malignancy(-ies), with the exception of non-melanoma skin cancer Subjects, who in the opinion of the Investigator, are likely to require escalating doses of vasopressors to attain and/or maintain hemodynamic stability Systemic immunosuppressive therapy that has not been stabilized for greater than 4 months, or in the case of chronic corticosteroid therapy, a dose of >15 mg/day of prednisone or the equivalent within the past 30 days Organ failure affecting more than 2 non-renal organs Platelet count <25,000/uL or other serious hematological abnormalities that would place subject in imminent danger of death Any prior medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Miller

Organizational Affiliation

Sentien Biotechnologies, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Lehigh Valley Hospital

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18101

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34581517

Citation

Swaminathan M, Kopyt N, Atta MG, Radhakrishnan J, Umanath K, Nguyen S, O'Rourke B, Allen A, Vaninov N, Tilles A, LaPointe E, Blair A, Gemmiti C, Miller B, Parekkadan B, Barcia RN. Pharmacological effects of ex vivo mesenchymal stem cell immunotherapy in patients with acute kidney injury and underlying systemic inflammation. Stem Cells Transl Med. 2021 Dec;10(12):1588-1601. doi: 10.1002/sctm.21-0043. Epub 2021 Sep 28.

Results Reference

derived

Learn more about this trial

A Study of Cell Therapy for Subjects With Acute Kidney Injury Who Are Receiving Continuous Renal Replacement Therapy

We'll reach out to this number within 24 hrs