A Phase 1 interventional study of HP802-247 in Normal Female Volunteers, sponsored by Healthpoint. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by Healthpoint (part of Smith & Nephew, Inc.) · Phase 1, Interventional, and Treatment
The goal for this study is to examine the persistence of growth arrested,allogeneic,male-donor keratinocytes and fibroblasts when applied as product HP802-247 to the surface of acute excisional wounds in health female volunteers, as measured using Y-STR for detection of Y-chromosome.
Healthpoint is the lead sponsor of 34 studies on the registry; none are open to participants now.
First submitted before Healthpoint became part of Smith & Nephew, Inc..
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days
Biological: HP802-247
One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin.
Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy.
The primary efficacy variable was detection of the full set of 17 Y STR loci. If all loci amplified such that a clear identification of a donor was possible, the test result was categorized as positive. If fewer loci amplified such that identification of the donor was not possible in a forensic setting, the result was categorized as negative. Descriptive statistics are presented for this variable.
Time frame: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks
Time in Days to 50% Correct Identification (ID50) of the Implanted Male DNA 17 Loci in Female Volunteers, With Regard to Three DNA Profile Types, Including Partial DNA Profile, > 50% DNA Profile, and Full (or Complete) DNA Profile.
The biopsy area was examined for the presence of the Y chromosome, based on the presence of a full set of Y-STR loci as well as partial sets, assayed by a commercial kit (AmpFISTRTM). Probit analysis was utilized to determine the time in days to 50% correct identification (ID50) of the implanted male DNA 17 loci in female volunteers, with regard to three DNA profile types, including partial DNA profile, \> 50% DNA profile, and full (or complete) DNA profile. The analysis was performed using SAS® PROC PROBIT
Time frame: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks
Subjects were enrolled at a single US investigational site, between September 14, 2010 and December 08, 2010.
| Milestone | HP802-247 |
|---|---|
| Started | 28 |
| Completed | 25 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Non-compliance | 2 |
The primary efficacy variable was detection of the full set of 17 Y STR loci. If all loci amplified such that a clear identification of a donor was possible, the test result was categorized as positive. If fewer loci amplified such that identification of the donor was not possible in a forensic setting, the result was categorized as negative. Descriptive statistics are presented for this variable.
| Participants | HP802-247 |
|---|---|
| Week 1, Day 8 | 3 |
| Week 2, Day 15 | 1 |
| Week 3, Day 22 | 0 |
| Week 4, Day 29 | 0 |
| Week 5, Day 36 | 0 |
| Week 6, Day 43 | 0 |
| Week 7, Day 50 | 0 |
| Week 8 Day 57 | 0 |
The biopsy area was examined for the presence of the Y chromosome, based on the presence of a full set of Y-STR loci as well as partial sets, assayed by a commercial kit (AmpFISTRTM). Probit analysis was utilized to determine the time in days to 50% correct identification (ID50) of the implanted male DNA 17 loci in female volunteers, with regard to three DNA profile types, including partial DNA profile, \> 50% DNA profile, and full (or complete) DNA profile. The analysis was performed using SAS® PROC PROBIT
| Days | HP802-247 |
|---|---|
| Partial DNA profile | 19 (0 to 30) |
| ≥ 50% of the 17 loci | 17 (0 to 28) |
| Complete DNA profile | 13 (0 to 24) |
Collected over Safety reporting occurred over the eight weeks of the study.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HP802-247 | — | 1/28 (3.6%) | 8/28 (28.6%) |
| Event | HP802-247 |
|---|---|
| Pelvic PainReproductive system and breast disorders | 1/28 |
| Event | HP802-247 |
|---|---|
| SinusitisInfections and infestations | 2/28 |
| FuruncleInfections and infestations | 1/28 |
| NasopharyngitisInfections and infestations | 1/28 |
| Urinary Tract Infection (UTI)Infections and infestations | 1/28 |
| Human BiteInjury, poisoning and procedural complications | 1/28 |
| Skin LacerationInjury, poisoning and procedural complications | 1/28 |
| Blood Cholesterol IncreaseInvestigations | 1/28 |
| Trigger FingerMusculoskeletal and connective tissue disorders | 1/28 |
| MigraineNervous system disorders | 1/28 |
| InsomniaPsychiatric disorders | 1/28 |
| Age, Categorical(Participants) | HP802-247 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 27 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | HP802-247 |
|---|---|
| Female | 28 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | HP802-247 |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 25 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | HP802-247 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
The record gives a start of Sep 2010, a primary completion of Dec 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2016, 5 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Topical Wound Spray HP802-247