Donislecel
- Gene therapy
- Still being tested
- Identity checked
- Sources last checked 2026-09-04
This page shows what was measured, who it was measured in, and what that does not settle.
What Donislecel does in the body
From the FDA-approved label: Pancreatic islets regulate blood glucose levels through secretion of multiple hormones in response to increases and decreases in blood glucose.
Endocrine cells within pancreatic islets release insulin, glucagon, somatostatin, pancreatic peptide, and ghrelin. Insulin stimulates glucose uptake by peripheral tissues; glucagon mobilizes glucose from the liver into circulation; somatostatin inhibits both α- and β-cell secretions; pancreatic peptide inhibits pancreatic exocrine secretion; and ghrelin inhibits insulin secretion. The primary mechanism of action of LANTIDRA is believed to be secretion of insulin by infused (transplanted) β- cells.
Why people take it. LANTIDRA is an allogeneic pancreatic islet cellular therapy indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
- Where it acts
- Not recorded.
- Kind of result
- No result is published, so no kind of result applies yet
- Supervision
- Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.
What the registries record it as
The substance registry classes this as mixture.
FDA substance registry · FW00DG4E3P · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 139 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in peopleRead from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
- Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
- What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
- Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
- Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
- A number that stands in for health No evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
- A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
- Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
- Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
- A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What is missing or unclearRead from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
- LANTIDRA is an allogeneic pancreatic islet cellular therapy indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Use LANTIDRA in conjunction with concomitant immunosuppression.
Who is missing from the studies
- Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of LANTIDRA have not been established in pediatric patients with type 1 diabetes.”
US prescribing information · 24610d9f-0c5a-4f55-93b3-d456300bfd5d · read 2026-08-30
On older people, the label states: “The safety and effectiveness of LANTIDRA have not been established in geriatric patients with type 1 diabetes and hypoglycemic unawareness.”
US prescribing information · 24610d9f-0c5a-4f55-93b3-d456300bfd5d · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Pregnancy risk has not been assessed for LANTIDRA.”
US prescribing information · 24610d9f-0c5a-4f55-93b3-d456300bfd5d · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary The risk of exposing a child to LANTIDRA components during breastfeeding has not been assessed.”
US prescribing information · 24610d9f-0c5a-4f55-93b3-d456300bfd5d · read 2026-08-30
Where the result stopped carrying
- This is a scope explorer, not a diagnosis engine.
- It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to takeRead from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
- It was studied for a different goal
- The studies measured something else entirely. Nothing in this record points to this reason.
- A different form was studied
- The studied form is not the form on the shelf. Nothing in this record points to this reason.
- There was nothing to correct
- Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
- Something else had to happen too
- In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
- The change is too small to feel
- A real change can still sit below what a person notices. Nothing in this record points to this reason.
- Day-to-day swing hides it
- Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
- Not enough time yet
- The studies ran longer than the person has waited. Nothing in this record points to this reason.
- It was not taken as studied
- Missed days change the result, and studies count them. Nothing in this record points to this reason.
- Something else changed at the same time
- Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
- The product may not be what it says
- Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
- No recorded reason
- RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to takeRead from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Still being tested
Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Intravascular
Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.
Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
The identity record classes it as CRISPR / Gene Therapy.
No source is stored against this line.
What is in the pack
Sold as solution, given by the intravascular route.
Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to takeNothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclearRead from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Intravascular
Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
1 product lists this as an active ingredient in the United States drug directory. 1 of them contain it and nothing else.
FDA National Drug Code directory · 73539-001 · read 2026-08-29
They are sold as solution, taken intravascular.
FDA National Drug Code directory · 73539-001 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 24610d9f-0c5a-4f55-93b3-d456300bfd5d · read 2026-08-29
Those labels are classed as cellular therapy.
US prescribing information · 24610d9f-0c5a-4f55-93b3-d456300bfd5d · read 2026-08-29
LANTIDRA is intravascular at 3 DOSAGE FORMS AND STRENGTHS LANTIDRA is a cellular suspension of allogeneic pancreatic islets (islets of Langerhans) in buffered transplant media containing sodium chloride, dextrose, minerals, amino acids, vitamins, a…, recorded as fda label in effect 2026-01-13 in the United States.
US prescribing information · 24610d9f-0c5a-4f55-93b3-d456300bfd5d · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to takeRead from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
- Which of the trials of Donislecel studied people like me?
- What was measured, and for how long?
- Was the result a laboratory value or a health outcome?
- What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclearRead from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
How fast does the body clear it?
The sources RNAWiki checked hold nothing for this field.
Why it matters. Without this, nothing on this page can say how long anything lasts.
What would answer it
A stored source that records it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Donislecel are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in peopleRead from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Where else this substance is registered
- FDA substance identifier (UNII)
- FW00DG4E3P
- RxNorm concept
- 2642264
Checks this page had to pass
Passed
Identity resolved
no open identity hold
Passed
No unresolved merge across substance families
no quarantine open
Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
Passed
Safety mode resolved
The identity record classes it as CRISPR / Gene Therapy.
Passed
Canonical metadata present
slug and display name present
What is missing or unclearRead from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
The earliest marketing start date recorded for a listed product is 20230628.
FDA National Drug Code directory · 73539-001 · read 2026-08-29
What is missing or unclearRead from sources, not yet reviewed
What to learn next
Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.
- Were people like me actually studied?
- How close is this evidence to something I would notice?
- What does nobody know about this yet?
- What is a biomarker?
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
- What was measured, goal by goal — found nothing in the sources checked.
- What happened in people — found nothing in the sources checked.
- The path through the body — found nothing in the sources checked.
- Felt, measured, or meaningful — found nothing in the sources checked.
- How long anything takes — found nothing in the sources checked.
- What it may clash with — found nothing in the sources checked.
- Other ways to the same goal — found nothing in the sources checked.
- Claims that go past the evidence — found nothing in the sources checked.
- What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (1)
Donislecel was tested only in human — what did it show?
human: mechanism-only (1): the rungs where Donislecel has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01
1 of 8 rungs carry a finding; no outcome wording is recorded.
Show the evidence
- humanmechanism-only; 1
recorded 2026-09-01 · last checked 2026-09-04
Where it is registered
Identifiers, relations and other names
The exact record
- UNII
- FW00DG4E3P
- ChEMBL id
- CHEMBL4594332
- RxCUI
- 2642264
- Trade name
- Lantidra
- Also called
- DONISLECEL [USAN], Donislecel [WHO-DD]
Sources (3)
Sources
- ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
- this record's own fields 2,3,5 ·
- Europe PMC and ClinicalTrials.gov organism ladder ·
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · derived from this page's own recorded fields; no external licence
How these records are assembled · Which registers were checked
Index-quality checks
- identity passed: no open identity hold
- required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
- public claims reviewed: 0 reviewed claim(s); drafts are never rendered
- source coverage passed: 3 source rows
- no critical contamination: no quarantine open
- canonical metadata passed: slug and display name present
- no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.