Solid Organ Transplant RejectionNCT05215288
Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients
A study testing ExoFlo in people with Solid Organ Transplant Rejection and Organ Rejection Transplants, run by Direct Biologics, LLC at 2 sites in United States.
Trial summary
This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression to severe or life-threatening condition related to rejection of an abdominal solid organ… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Organ Transplant Rejection, Organ Rejection Transplants, Organ Rejection
- What is being tested?
- ExoFlo
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, ages 18 to 75.
- Previous abdominal solid organ transplant, including intestinal transplant.
- Diagnosis of acute or chronic rejection / inflammation based on clinical observations, laboratory analysis, histological evaluation.
- Diagnosis of worsening allograft function based on clinical observations, laboratory analysis, histological evaluation.
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- Failed primary and alternate standard of care therapies.
- Serious or life-threatening condition or progressing to serious or life-threatening condition if not treated as evaluated by the treating physician.
- In otherwise good general health as evidenced by medical history.
- Male or female of reproductive potential must utilize a medically effective birth control method during from time of enrollment to 6 months after last dose of IMP.
Who cannot join
- Pregnant or breastfeeding.
- Treatment with another investigational drug or other intervention within 30 days of enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Direct Biologics Investigational Site
Palo Alto, California, 94304
Direct Biologics Investigational Site
San Francisco, California, 94143
About this study
Official title: Intermediate Size Expanded Access for the Use of ExoFlo in the Treatment of Abdominal Solid Organ Transplant Patients Who Are at Risk of Worsening Allograft Function With Conventional Immunosuppressive Therapy Alone
This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression to severe or life-threatening condition related to rejection of an abdominal solid organ transplant, at risk of worsening allograft function, or at risk of complications from current immunosuppressive therapeutic regimens.
Read the detailed description
Objectives:
The primary objective of this expanded access program is to evaluate safety and tolerability of ExoFlo in patients with graft inflammation, or worsening graft function, or evidence of rejection of an abdominal solid organ transplant despite conventional therapies. The secondary objective is to characterize the improvement seen in serum inflammatory markers and inflammation of solid abdominal organ.
Endpoints:
Primary Endpoint:
Incidence of AEs or SAEs.
Secondary Endpoint:
Improvement seen in serum inflammatory markers and inflammation of solid abdominal organ. This could include improvements seen in the following transplant types:
- Liver transplant: overall improved liver function, as seen by reduction in liver function test and improved albumin.
- Small bowel transplant: decreased inflammation on biopsy
- Pancreas: decreased amylase and lipase
- Multivisceral: any of the above criteria
Number of subjects: 20
Phase: Expanded Access Protocol
- Being tested
- ExoFlo
- Keywords
- ExoFlo, Organ Rejection, Organ Rejection Transplants, Solid Organ Transplant Rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExoFloBiological
Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Direct Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bill Arana, Study director, Direct Biologics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215288
- Sponsor's protocol ID
- DB-EF-TP_ASO-1a
- Status last verified
- Jul 2024
- First submitted
- 18 Jan 2022
- Last updated
- 29 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate Size Expanded Access for the Use of ExoFlo in the Treatment of Abdominal Solid Organ Transplant Patients Who Are at Risk of Worsening Allograft Function With Conventional Immunosuppressive Therapy Alone
- ClinicalTrials.gov ID
- NCT05215288
- Acronym / sponsor ID
- DB-EF-TP_ASO-1a
- Keywords
- ExoFlo, Organ Rejection, Organ Rejection Transplants, Solid Organ Transplant Rejection
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Direct Biologics, LLCIndustry (pharma, biotech, devices)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression to severe or life-threatening condition related to rejection of an abdominal solid organ transplant, at risk of worsening allograft function, or at risk of complications from current immunosuppressive therapeutic regimens.
Detailed description
Objectives:
The primary objective of this expanded access program is to evaluate safety and tolerability of ExoFlo in patients with graft inflammation, or worsening graft function, or evidence of rejection of an abdominal solid organ transplant despite conventional therapies. The secondary objective is to characterize the improvement seen in serum inflammatory markers and inflammation of solid abdominal organ.
Endpoints:
Primary Endpoint:
Incidence of AEs or SAEs.
Secondary Endpoint:
Improvement seen in serum inflammatory markers and inflammation of solid abdominal organ. This could include improvements seen in the following transplant types:
- Liver transplant: overall improved liver function, as seen by reduction in liver function test and improved albumin.
- Small bowel transplant: decreased inflammation on biopsy
- Pancreas: decreased amylase and lipase
- Multivisceral: any of the above criteria
Number of subjects: 20
Phase: Expanded Access Protocol
Study design
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, ages 18 to 75.
- Previous abdominal solid organ transplant, including intestinal transplant.
- Diagnosis of acute or chronic rejection / inflammation based on clinical observations, laboratory analysis, histological evaluation.
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding.
- Treatment with another investigational drug or other intervention within 30 days of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExoFloIntravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Direct Biologics, LLCLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bill Arana study director
Direct Biologics, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExoFlo in people with Solid Organ Transplant Rejection and Organ Rejection Transplants, run by Direct Biologics, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.