This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Autologous Cell Therapy for Treatment of Fecal Incontinence (NCT01600755), a na phase 1, phase 2 study. The primary outcome is Number of Treatment-Related Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01600755 |
| Phase | Phase 1, Phase 2 |
| Condition | Fecal Incontinence |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 53 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cook MyoSite |
| Results posted | Yes |
2. Clinical Question
Population
Adults with fecal incontinence were the population of interest. The registry record gives an enrollment of 53, but does not report further eligibility details or the number included in each outcome analysis.
Intervention
Participants received iltamiocel, an autologous muscle-derived cell product prepared from a patient’s own cells. The study product was administered as a single intrasphincteric injection of 250 x 10^6 cells.
Comparator
There was no randomized comparator group. This was a nonrandomized, single-group study, so the registry record does not provide a like-for-like control arm for estimating a treatment contrast.
Primary question
The primary endpoint was the number of treatment-related adverse events through 12 months after treatment. The stated assessment concerned the frequency and severity of events related to the study product and study procedures.
The study’s stated aim was to investigate safety and feasibility of injecting autologous muscle-derived cells into the anal sphincter for fecal incontinence. Secondary outcomes covered fecal incontinence episodes and days with episodes, categorical reductions in episode counts, and changes in patient-reported quality of life and symptom severity. These measures represent different aspects of the condition and are not interchangeable.
Because the design included one treatment group and no randomized control, changes recorded after treatment would not, by themselves, distinguish treatment effects from natural variation, changes over time, or other influences. The registry record does not report numerical results for the primary endpoint or the listed secondary outcomes. The available safety counts therefore do not answer whether incontinence episodes, quality of life, or symptom severity changed.
3. Trial Design
This was a prospective, nonrandomized, single-group study listed as phase 1 and phase 2. The registry record describes enrollment of 53 participants and a single study intervention, iltamiocel. There was no random allocation and no masking. The design therefore focused on observing participants who received the study product rather than comparing randomized groups.
Iltamiocel is described as autologous muscle-derived cells, meaning cells prepared from a patient’s own cells. The study arm description specifies a single intrasphincteric injection of 250 x 10^6 cells. The registry record identifies the condition as fecal incontinence and states that the study aimed to investigate the safety and feasibility of injection into the anal sphincter.
The primary outcome was the number of treatment-related adverse events, assessed through 12 months following treatment. The description refers to both frequency and severity and includes events related to the study product and study procedures. Secondary outcomes included the median number of fecal incontinence episodes and days with episodes in a 28-day diary; categorical reductions in episode counts; and changes from baseline in patient-reported quality of life and symptom severity.
Although enrollment was 53, the registry record does not report how many participants contributed data to each outcome, whether every participant completed follow-up, or how missing observations were handled. It also does not report a detailed statistical analysis plan, sample-size justification, or analysis populations. The study is marked completed, but completion status does not supply outcome estimates or establish that all planned assessments were available.
The single-group structure is central to interpretation. Safety events can be counted among treated participants, but without a control group those counts do not establish how event rates compare with what would otherwise have occurred. Similarly, before-and-after outcome changes, if reported, would be descriptive evidence in this design rather than a randomized estimate of a causal treatment effect.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Iltamiocel |
|---|---|
| STARTED | 53 |
| Iltamiocel Injection | 48 |
| 3-Month Follow-Up | 48 |
| 6-Month Follow-Up | 48 |
| 12-Month Follow-Up | 47 |
| COMPLETED | 47 |
| NOT COMPLETED | 6 |
Reasons for not completing this period:
| Reason | Iltamiocel |
|---|---|
| Withdrawal by Subject | 6 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Iltamiocel |
|---|---|---|
| Participants analysed | 48 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 24 |
| Age, Categorical: >=65 years | Participants | 24 |
| Age, Continuous | years | 61.7 (SD 13.3) |
| Sex: Female, Male: Female | Participants | 45 |
| Sex: Female, Male: Male | Participants | 3 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 47 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 44 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: Canada | participants | 33 |
| Region of Enrollment: United Kingdom | participants | 15 |
| 28-Day Incontinence Diary (Number of Episodes) | Incontinence Episodes/28 Days | 16 (0 to 92) |
| 28-Day Incontinence Diary (Days with Episodes) | Days with incontinence episodes | 12 (0 to 28) |
| Cleveland Clinic Incontinence Score (CCIS) | scores on scales | 13.6 (SD 2.9) |
| Fecal Incontinence Quality of Life (FIQL) Questionnaire: FIQL - Lifestyle scale | scores on scales | 2.5 (SD 0.9) |
| Fecal Incontinence Quality of Life (FIQL) Questionnaire: FIQL - Coping/behavior scale | scores on scales | 1.7 (SD 0.6) |
| Fecal Incontinence Quality of Life (FIQL) Questionnaire: FIQL - Depression/perception scale | scores on scales | 2.5 (SD 0.9) |
| Fecal Incontinence Quality of Life (FIQL) Questionnaire: FIQL - Embarrassment scale | scores on scales | 1.9 (SD 0.8) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Treatment-Related Adverse Events, measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint counts treatment-related adverse events through 12 months after treatment. Its registry description includes events related to both the study product and study procedures, and says that frequency and severity were assessed. A count endpoint represents the number of events rather than a continuous measurement such as a score or a time-to-event estimate. The registry record does not provide an event definition, severity grading rules, or a breakdown of the primary endpoint by severity.
Safety and feasibility are important questions when a study evaluates a cell product delivered through a procedure. Counting events can describe the burden of recorded events during the specified follow-up period and can help identify what requires closer characterization in later research. However, a count alone does not establish that an event was caused by the product or procedure; attribution depends on the study’s assessment process, details of which are not reported in the registry record.
The posted results do not report a numerical result for this primary endpoint. The adverse-event record separately gives counts of participants with serious and other adverse events, but it does not provide a total treatment-related event count or establish that those categories correspond directly to the primary endpoint. These safety summaries should therefore not be substituted for a reported primary endpoint estimate.
Interpretation also depends on the observation period and on how repeated events and incomplete follow-up were handled. The 12-month timeframe is stated, but the registry record does not report rules for counting recurrent events, handling events with uncertain attribution, or accounting for participants with incomplete observation. Those details are needed to understand exactly how a count was constructed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a completed single-group study with enrollment of 53 and identifies a primary safety endpoint, but it does not report a numerical result for that endpoint. It also lists eight outcome measures and zero analyses in the record. No estimates, confidence intervals, or hypothesis-test results for the primary or secondary outcomes are reported. As a result, the available record does not quantify change in fecal incontinence episodes, days with episodes, quality of life, or symptom severity.
The safety information reports that 4 participants had serious adverse events and 31 had other adverse events, each among 53 participants at risk. The record also lists serious adverse-event terms with percentages. These are descriptive counts from the treated group; the record does not provide a control group against which to judge whether the counts are higher or lower than a comparison rate. Nor does it give enough detail to equate these counts with treatment-related events in the primary endpoint.
Frequency and severity are distinct features of safety. A participant count indicates how many participants were affected, while an event count can include more than one event for a participant. The registry labels the primary endpoint as a number of events, but the safety fields report participants affected. The record does not state the total number of events represented by those affected-participant counts, nor does it report a complete severity distribution.
Terms and percentages in the serious-event listing describe reported event categories. A listed term does not establish that an event was caused by iltamiocel or by the injection, and the record does not provide a comparator for contextualizing the listed percentages. Some participants may have experienced more than one event; the registry record does not specify whether categories overlap at the participant level. Accordingly, the term-specific percentages should be read as safety-reporting descriptors, not as comparative estimates.
Prospective collection and a defined follow-up timeframe can organize safety observation, but they do not eliminate uncertainty due to the lack of a control group, unreported follow-up completeness, or unreported event-adjudication details. The registry record does not report interim analyses or a detailed statistical plan. It also does not report whether outcome estimates were adjusted or how the secondary measures were analyzed. These omissions prevent a fuller assessment of precision, multiplicity, and the handling of incomplete observations.
The defensible statistical reading is therefore limited: the registry record documents a one-group study and reports adverse-event participant counts, while numerical results for the stated primary and secondary efficacy-related outcomes are not reported in the registry record. The posted information does not support a causal comparison or a precise estimate of change in symptoms. It does provide a description of the study’s intended safety focus and some observed safety categories, with important uncertainty about event counts, attribution, and analysis methods.
9. Statistical Methods Explained
Statistical methods determine how observations are converted into estimates and how uncertainty is represented. For this study, the registry record identifies a count of treatment-related adverse events as the primary endpoint. It does not report the statistical model, estimation method, confidence intervals, or hypothesis tests used for that endpoint. It also does not report an analysis plan for the secondary outcomes. The concepts below are general explanations, not a description of unreported methods used in this study.
What does a count endpoint represent?
A count endpoint records how many events occur during a defined observation period. It differs from a binary endpoint, which records whether a participant had at least one event, and from a continuous endpoint, which measures a quantity such as a questionnaire score. If one participant experiences repeated events, the event total can exceed the number of participants affected. A study must specify whether its reported number refers to events, participants with events, or both. The registry record names the primary outcome as a number of events, while the adverse-event information also reports participants affected; it does not provide enough detail to reconcile the two summaries.
Count data can have a skewed distribution and may show over-dispersion. Over-dispersion means the observed variation is greater than a simple count model would expect. In general, if over-dispersion is present, a model that assumes less variation may produce confidence intervals that are too narrow and tests that are too optimistic. Suitable analysis depends on the data structure, follow-up time, recurrence, and modeling assumptions. The registry record does not report whether any count model was used or whether over-dispersion was assessed.
Why does the single-group design matter?
A single-group study can describe what happened among treated participants. It cannot, on its own, estimate a randomized contrast between treatment and control. For an outcome measured before and after treatment, the observed change may reflect treatment, but it may also reflect natural fluctuation, regression to the mean, changes in reporting, or other events over time. In general, a randomized control group helps separate treatment effects from such influences because allocation balances known and unknown factors on average. This study was nonrandomized and had no comparator arm, so that kind of contrast is unavailable in the registry record.
Blinding is another design feature that can affect measurement. The record lists no masking. For patient-reported diary and questionnaire outcomes, awareness of treatment can influence reporting or expectations. That possibility is a general methodological concern, not evidence that reporting was biased in this study. The registry record does not describe procedures intended to limit such influence.
How should precision be assessed?
A confidence interval is a range of values compatible with the observed data under a specified statistical method. In general, it conveys precision: a narrower interval indicates less statistical uncertainty than a wider interval, while still depending on the model and assumptions. A point estimate without an interval gives less information about precision. No confidence intervals or numerical estimates for the primary or secondary outcomes are reported in the registry record, so precision cannot be assessed for those outcomes.
A p-value, when reported, describes how compatible data are with a specified null hypothesis under a statistical model. It does not measure the size or importance of an effect, and it does not establish causation. No p-values or hypothesis tests for the clinical outcomes are reported in the registry record. In a single-group study, a within-group test of change would not create a randomized comparison or remove the design’s limitations.
What do planning illustrations mean?
Sample-size planning uses assumptions about the expected effect, variability, significance level, and desired power to estimate how many participants a future comparison might require. The registry record describes a planning illustration based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It specifies that time-to-event planning uses a total event count and other planning figures refer to participants per arm. These are planning conventions, not results observed in this study and not evidence that the trial had a particular probability of detecting an effect.
The record explicitly characterizes the illustration as not being the trial’s own design. It should not be interpreted as a sample-size justification for enrollment of 53, as an observed power calculation, or as evidence that a study effect was established. The record does not report the protocol’s original sample-size rationale. Because the trial itself had one group, an illustration based on equal allocation between two arms does not describe its actual allocation.
What is not documented?
The registry record does not report whether analyses were prespecified, whether any adjustments were made, how repeated observations were modeled, or how missing diary and questionnaire data were handled. It does not state how treatment-relatedness was adjudicated or how recurrent adverse events were counted. These are not minor technical details: different rules can yield different estimates and uncertainty. Without them, readers cannot reproduce the analyses or determine whether the posted adverse-event counts align with the primary endpoint definition.
10. Multiplicity, Missing Data and Analysis Populations
The study lists several secondary outcomes spanning diary-based episode counts, days with episodes, categorical reductions in episodes, quality of life, and symptom severity. Testing or interpreting many outcomes raises a general multiplicity concern: the more comparisons considered, the greater the chance that some appear notable by chance alone. In general, a prespecified hierarchy, adjustment procedure, or clearly labeled exploratory interpretation can help readers understand how multiple outcomes were handled. The registry record does not report a multiplicity strategy, an outcome hierarchy beyond identifying the primary endpoint, or analyses for the listed secondary outcomes.
The record does not report a detailed analysis plan, interim analyses, or analysis populations. It therefore does not establish whether the reported safety summaries include all enrolled participants, all treated participants, or a defined subset. Enrollment is 53, and safety fields identify 53 participants at risk, but outcome-specific denominators and participant flow are not reported. Those details matter because the amount and pattern of missing data can affect both estimates and their precision.
Missing diary days or questionnaire responses can reduce the information available and may bias results if missingness is related to symptoms, adverse events, or treatment experience. General approaches include analyzing available observations, imputing missing values under stated assumptions, or conducting sensitivity analyses. The registry record does not report which approach, if any, was used for the secondary outcomes. It also does not report how incomplete follow-up was handled for the 12-month safety assessment.
These gaps limit assessment of selective reporting and robustness. The record lists eight outcome measures but does not provide outcome analyses. Without a documented analysis population, missing-data method, and multiplicity approach, readers cannot determine how complete the evidence is or how much emphasis was placed on any particular outcome.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Iltamiocel | 4 | 53 | 7.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Iltamiocel | 0 of 53 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Iltamiocel | 31 of 53 |
Most frequent serious adverse event terms
| Event term | Organ system | Iltamiocel |
|---|---|---|
| Pneumonia | Infections and infestations | 2 of 53 |
| Urinary tract infection | Infections and infestations | 1 of 53 |
| Urosepsis | Infections and infestations | 1 of 53 |
| Nephrotic syndrome | Renal and urinary disorders | 1 of 53 |
| Sinus operation | Surgical and medical procedures | 1 of 53 |
| Small intestine obstruction | Gastrointestinal disorders | 1 of 53 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Iltamiocel |
|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | 14 of 53 |
| Diarrhea | Gastrointestinal disorders | 8 of 53 |
| Lower respiratory tract infection | Infections and infestations | 6 of 53 |
| Urinary tract infection | Infections and infestations | 5 of 53 |
| Post procedural contusion | Injury, poisoning and procedural complications | 5 of 53 |
| Hypoesthesia | Nervous system disorders | 5 of 53 |
| Nasopharyngitis | Infections and infestations | 4 of 53 |
| Hemorrhoids | Gastrointestinal disorders | 3 of 53 |
| Proctalgia | Gastrointestinal disorders | 3 of 53 |
| Cystitis | Infections and infestations | 3 of 53 |
Serious events with the highest arm-level rate: pneumonia (3.8%), urinary tract infection (1.9%), urosepsis (1.9%), nephrotic syndrome (1.9%), sinus operation (1.9%).
The adverse-event information reports serious adverse events in 4 participants among 53 at risk and other adverse events in 31 participants among 53 at risk. No deaths are reported. The serious-event terms listed include pneumonia at 3.8%, and urinary tract infection, urosepsis, nephrotic syndrome, sinus operation, and small intestine obstruction, each at 1.9%. These are descriptive safety entries, not comparisons with an untreated or randomized control group.
The figures for participants affected should not be mistaken for a total count of events. A participant can experience more than one event, and the registry record does not state whether the listed categories overlap. It also does not say whether the serious-event term percentages represent participants or events in every category. The percentages therefore describe the registry’s serious-event listing but do not establish a participant-level risk for each term.
The primary endpoint concerns treatment-related events through 12 months, whereas the adverse-event fields separately summarize affected participants and serious-event terms. The record does not report how many events were judged treatment-related, how attribution was determined, or whether the adverse-event counts cover the same period and population as the primary endpoint. The serious-event counts cannot be substituted for a primary-endpoint total.
In a single-group study, these counts characterize observations among participants who received the intervention. Without a comparator, they cannot show whether the frequency is greater or lower than it would have been under another condition. They also do not establish that any particular event was caused by the product or procedure.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a prospective, nonrandomized study evaluated autologous muscle-derived cell transplantation in participants with fecal incontinence. It describes a single-group intervention, a 12-month primary safety endpoint, and several diary-based and patient-reported secondary outcomes. The adverse-event information reports participant counts and serious-event terms. These registry entries describe the study’s scope and the safety information posted in the registry.
The record does not report a numerical primary endpoint result or analyses of the listed secondary outcomes. Consequently, it does not provide an estimate of treatment-related adverse-event frequency as defined by the primary endpoint, nor does it quantify change in fecal incontinence episodes, days with episodes, quality of life, or symptom severity. The presence of outcome names in a registry is not evidence that results were reported for those outcomes.
The single-group design also limits causal interpretation. Even if pre-treatment and post-treatment values were available, changes over time would not establish that the intervention caused the changes. Without randomization and a comparator, other explanations remain possible. The registry record does not permit a like-for-like treatment contrast.
Safety counts should be read with similar care. They document participants affected by reported adverse-event categories, but they do not by themselves determine causation, event recurrence, or comparative risk. The registry record does not provide the full event-level detail needed to align those counts with the treatment-related event count named as the primary endpoint.
Thus, the posted information supports a description of design, intended outcomes, and selected safety counts, but not a conclusion about clinical benefit or comparative safety. The absence of reported outcome analyses is a limitation of the registry record, not evidence that an outcome did or did not occur. Any broader interpretation would require additional results and methodological detail not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable because its design and endpoint make the distinction between describing outcomes and estimating comparative effects especially important. A prospective single-group study can record adverse events and follow symptom measures over time. However, without a randomized comparator, observed patterns cannot separate intervention-related changes from other changes that occur during follow-up. The study’s nonrandomized structure therefore places clear limits on causal interpretation.
The primary endpoint is a count of treatment-related adverse events, while the adverse-event summary also reports participants affected. Those are different quantities. A participant-based count answers how many people experienced an event category; an event count answers how many events occurred. Recurrent events and attribution rules can affect the interpretation, yet the registry record does not report enough detail to reconcile the endpoint with the posted safety fields.
The breadth of secondary outcomes is also relevant. Diary measures, categorical thresholds, and patient-reported questionnaires address different dimensions of fecal incontinence. They can yield complementary information, but multiple outcomes require transparent plans for analysis and interpretation. The registry record lists these outcomes without reporting their numerical analyses, and it does not describe multiplicity handling or missing-data methods.
Finally, the record illustrates why enrollment alone is not a result. Enrollment of 53 and completion status do not reveal the precision of an outcome estimate, the number of participants with complete follow-up, or whether the stated questions were answered. A clear statistical account requires outcome estimates, denominators, uncertainty, and analysis details. Those elements are not reported for the primary and secondary outcomes in this record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations are specific to interpreting this trial record. First, the study is a nonrandomized single-group investigation with no like-for-like control. This prevents direct estimation of a comparative treatment effect and leaves changes over time open to alternative explanations. The registry record itself flags that the arms are not a like-for-like control comparison, consistent with the one-group design.
Second, the registry record does not report numerical analyses for the primary endpoint or secondary outcomes. It gives no primary event total, effect estimate, confidence interval, or analysis result for the diary and questionnaire measures. This means both the magnitude and precision of any outcome change are unavailable from the record.
Third, the safety information distinguishes participants affected from the primary endpoint’s number of treatment-related events, but the relationship between these summaries is not explained. Event recurrence, attribution procedures, severity grading, category overlap, and the full follow-up distribution are not reported. As a result, the counts and serious-event terms cannot be interpreted as a complete event-level account or as a comparative safety estimate.
Fourth, enrollment does not establish the denominator for every analysis. The registry record does not report participant flow, outcome-specific completion, handling of missing diaries or questionnaires, or analysis populations. It also does not report whether outcomes were adjusted for other factors, how repeated observations were treated, or how multiple secondary outcomes were addressed.
Finally, the record describes a planning illustration but does not report the original sample-size justification for this single-group study. The illustration’s two-arm assumptions do not describe the trial’s actual design. These limitations constrain reproducibility and interpretation; they do not establish that unreported methods were absent from study conduct, only that they are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Autologous Cell Therapy for Treatment of Fecal Incontinence — NCT01600755.
- Registry record last updated 2024-02-16; status last verified 2023-06.
- Results first posted 2024-02-16.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed prospective, nonrandomized phase 1/2 single-group study of iltamiocel for fecal incontinence, with enrollment of 53. The intervention was a single intrasphincteric injection of 250 x 10^6 autologous muscle-derived cells. The primary endpoint was the number of treatment-related adverse events through 12 months. Listed secondary outcomes included diary measures, categorical reductions in episode counts, and patient-reported quality of life and symptom severity.
The adverse-event information reports serious events in 4 participants and other events in 31 participants, with 53 at risk in each category, and no deaths. Serious-event terms and percentages are listed in the registry record. Numerical results for the primary endpoint and secondary outcome analyses are not reported in the registry record. The single-group design does not provide a randomized comparator, and details about missing data, analysis populations, multiplicity, and event-counting methods are also not reported.