Immune ToleranceNCT05010174
Long-term Safety Follow-up in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products
An observational study of Immune Tolerance, run by Medeor Therapeutics, Inc. at 1 site in United States.
Trial summary
At the completion of primary follow-up of various Medeor Transplant studies (called parent studies), subjects receiving Medeor's cellular immunotherapy products will be followed annually for up to an additional 84 months (7 years), in order to evaluate for long-term safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Tolerance
- What is being tested?
- MDR product
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 30 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney transplant recipients who received Medeor's cellular immunotherapy in previous Medeor studies
Who may be able to join
- Able and willing to fully comply with all study procedures and restrictions.
- Able to understand and provide written, signed, and dated informed consent to participate in the study in accordance with ICH GCP Guideline and all applicable local regulations.
- Have previously completed a Medeor study and received a Medeor cellular immunotherapy product
Who cannot join
- Has any condition or circumstance, which in the opinion of the Investigator would significantly interfere with the subject's protocol compliance or put the subject at increased risk.
- Unable or unwilling to provide written, signed, and dated informed consent to participate in the study.
- Has undergone a second organ transplant with an organ derived from an individual other than the donor of the transplant kidney received during a Medeor study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extension Study to Assess the Long-Term Safety in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products
At the completion of primary follow-up of various Medeor Transplant studies (called parent studies), subjects receiving Medeor's cellular immunotherapy products will be followed annually for up to an additional 84 months (7 years), in order to evaluate for long-term safety.
Read the detailed description
Study MDR-105-SAE is intended to be the long-term safety monitoring extension of Medeor's cellular immunotherapy, kidney transplant clinical studies. This Master Protocol has been created in order to establish a single database for all long-term safety data for those subjects that have received Medeor's cellular products. This Master Protocol will provide up to 84 months (7 years) of additional follow-up.
Long-term safety of subjects treated with Medeor's cellular immunotherapy has not been assessed. This study will collect the data into a centralized database allowing for continuous monitoring of any important safety signals.
- Conditions
- Immune Tolerance
- Being tested
- MDR product
- Keywords
- Long-term follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDR productDrug
Observation of patients previously receiving MDR product(s)
| Study group | Role | What they receive |
|---|---|---|
| Observational, long-term safety follow-up of patients who have received MDR product | Only patients who have received treatment with MDR product will be eligible for this study. Receives: Drug: MDR product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoints
Incidence of serious adverse events (SAEs), adverse events (AEs) leading to study withdrawal, and hospitalizations.
Measured: Through study completion, up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start11 May 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ToleranceStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medeor Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lenuta Micsa, MD, Study director, Medeor Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010174
- Sponsor's protocol ID
- MDR-105-SAE
- Status last verified
- Jun 2024
- First submitted
- 2 Aug 2021
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study to Assess the Long-Term Safety in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products
- ClinicalTrials.gov ID
- NCT05010174
- Acronym / sponsor ID
- MDR-105-SAE
- Conditions
- Immune Tolerance
- Keywords
- Long-term follow-up
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medeor Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 18 Aug 2021 (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.
At the completion of primary follow-up of various Medeor Transplant studies (called parent studies), subjects receiving Medeor's cellular immunotherapy products will be followed annually for up to an additional 84 months (7 years), in order to evaluate for long-term safety.
Detailed description
Study MDR-105-SAE is intended to be the long-term safety monitoring extension of Medeor's cellular immunotherapy, kidney transplant clinical studies. This Master Protocol has been created in order to establish a single database for all long-term safety data for those subjects that have received Medeor's cellular products. This Master Protocol will provide up to 84 months (7 years) of additional follow-up.
Long-term safety of subjects treated with Medeor's cellular immunotherapy has not been assessed. This study will collect the data into a centralized database allowing for continuous monitoring of any important safety signals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational, long-term safety follow-up of patients who have received MDR product | – | Drug: MDR productOnly patients who have received treatment with MDR product will be eligible for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients who received Medeor's cellular immunotherapy in previous Medeor studies
Key inclusion criteria (3 listed)
- Able and willing to fully comply with all study procedures and restrictions.
- Able to understand and provide written, signed, and dated informed consent to participate in the study in accordance with ICH GCP Guideline and all applicable local regulations.
- Have previously completed a Medeor study and received a Medeor cellular immunotherapy product
Key exclusion criteria (3 listed)
- Has any condition or circumstance, which in the opinion of the Investigator would significantly interfere with the subject's protocol compliance or put the subject at increased risk.
- Unable or unwilling to provide written, signed, and dated informed consent to participate in the study.
- Has undergone a second organ transplant with an organ derived from an individual other than the donor of the transplant kidney received during a Medeor study.
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 |
|---|---|---|
| MDR productObservation of patients previously receiving MDR product(s) | Drug | Observational, long-term safety follow-up of patients who have received MDR product |
Primary outcome
Safety Endpoints
Time frame: Through study completion, up to 7 years
Incidence of serious adverse events (SAEs), adverse events (AEs) leading to study withdrawal, and hospitalizations.
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Lenuta Micsa, MD study director
Medeor Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Tolerance, run by Medeor Therapeutics, Inc. at 1 site 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Lack of funding). 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.
What does the primary outcome measure?
Safety Endpoints (time frame: Through study completion, up to 7 years). It is what the study was designed to measure, not a finding.
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 7 Jun 2024.