Esophageal DiseasesPhase 1NCT05877300
Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
A Phase 1 study testing CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus and CEI Extra-Thoracic Subdermal Surgical Implantation - Cellspan™ Esophageal Implant-Adult (CEI) in patients that have had a previous partial esophagectomy in people with Esophageal Diseases, run by Harvard Apparatus Regenerative Technology, Inc. at 3 sites in United States.
Trial summary
Cellspan™ Esophageal Implant-Adult (CEI) The CEI is a combination product consisting of an engineered synthetic scaffold (device constituent) seeded and cultured with the patient's adipose derived mesenchymal stem cells (biologic constituent), intended to stimulate regeneration of a structurally intact, living… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Diseases
- What is being tested?
- CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus and CEI Extra-Thoracic Subdermal Surgical Implantation - Cellspan™ Esophageal Implant-Adult (CEI) in patients that have had a previous partial esophagectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jul 2023to 16 Oct 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Subject ≥18 years of age
- The patient has medical conditions requiring esophageal reconstruction, such as, but not limited to:
- Refractory benign esophageal strictures (RBES)
- Esophageal perforation (full thickness)
- Chronic/persistent esophageal fistula
- Combination of esophageal perforations/fistula with RBES
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- The patient must have failed at least 3 previous treatment modalities to correct the medical esophageal condition (a-d).
- If RBES: i. Steroid treatment ii. Esophageal balloon dilation (EBD) iii. Stent use ≥ 6 months iv. Endoscopic incisional repair
- If esophageal perforation: i. Fibrin glue ii. Endoscopic clips and/or suturing iii. Stent use ≥ 6 months iv. Primary surgical repair
- If Chronic/Persistent fistula(e): i. Fibrin glue ii. Endoscopic clips and/or suturing iii. Stent ≥ 6 months iv. Primary surgical repair
- If Combination Perforation/fistula with RBES i. Fibrin glue ii. Endoscopic clips and/or suturing iii. Stent use ≥ 6 months iv. Primary surgical repair
- The patient must be a surgical candidate for a short segment esophageal reconstruction (≤6 cm full circumferential segmental excision)
- The location of the esophageal segment for surgical resection is within the thoracic cavity, defined as, above the diaphragm and at least 4 cm below the larynx.
- The patient must be a high-risk candidate for minimally invasive esophageal reconstruction, based upon the investigator's determination. The patient requires a thoracotomy to repair the esophagus and is not amenable for laparoscopic or robotic minimally invasive gastric pull-up (GPU) surgery, due to a medical contraindication
- All patients must be made aware and must be amenable to a delayed rescue repair surgical procedure in the event the CEI fails to restore a patent durable biologic esophageal conduit
- The patient/guardian is willing and able to comply with the protocol specified medication regimen and follow-up evaluations
- The patient/guardian has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
- Subject ≥18 years of age
- The patient has medical conditions requiring esophageal reconstruction, limited to:
- Spit Fistula with an upper esophageal ostomy in the neck
- Patients may require esophageal de-functioning with a resulting cervical spit fistula if they are not candidates for immediate esophageal reconstruction. This may occur for multiple reasons, including being too sick for reconstruction, healing of the airway after tracheo-esophageal fistula repair, requirement for further therapy prior to reconstruction, or recovering from sepsis due to esophageal perforation.
- The patient must be a surgical candidate for a short segment esophageal reconstruction (< 7cm), a full circumferential segmental esophageal extension in order to have sufficient length to make the anastomosis to the distal thoracic esophagus, to a gastric or to an intestinal interposition conduit that will re-establish oral nutritional intake. i.
- Patient must be a high-risk candidate for the standard of care treatment of esophageal reconstruction, based upon the investigator's determination. The patient requires a thoracotomy to repair the esophagus following the CEI subdermal extension procedure and is not amenable for laparoscopic or robotic minimally invasive gastric pull-up (GPU) surgery.
- All patients must be made aware and must be amenable to a delayed rescue repair surgical procedure in the event the CEI fails to mature in the subdermal area prior to mobilization
- The patient/guardian is willing and able to comply with the protocol- specified medication regimen and follow-up evaluations
- The patient/guardian has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).
Who cannot join
- Subject requires or undergoes an esophageal segmental excision >6 cm in length
- Esophageal segment extends below the diaphragm or <4 cm below larynx
- Pre-existing implants/structures adjacent to target surgical location for implant that could cause abrasion of the scaffold/regenerated tissue (e.g., pacemaker lead, vascular clips, vascular grafts).
- Known clinical contraindication that would obfuscate the use of the covered metallic stent to be used as an adjunct to the procedure
- Post ablation stricture for Barrett's esophagus treated less than 1 year prior to planned procedure
- Patient has a comorbidity or contraindication that would preclude any study required procedures including adipose tissue biopsy and esophageal resection surgery. Comorbidities are defined from a subset of the Charlson Comorbidities Index (CCI, Yamashita 2018) scoring system and include:
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- diabetes mellitus (CCI = 1)
- connective tissue disorders (CCI=1)
- immune compromised
- chemotherapy radiotherapy or chemoradiotherapy (within 60 day clearance)
- inability to tolerate major thoracotomy
- active infection at the biopsy or thoracotomy incision site
- peripheral vascular disease (CCI=1)
- all patients with a CCI> 2
- Life expectancy of less than 1 year
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7days prior to index procedure.
- Has a known untreated neurological, psychological, psychiatric, or other disorder that would interfere with trial endpoints or with cooperation with the requirements of the trial
- Has a diagnosis of immunodeficiency, receiving cancer therapy including chimeric antigen receptor T cells (CAR-T), receiving systemic steroid therapy (>10 mg prednisone or equivalent daily dose), or any other form of pharmacologic therapy that would inhibit the intended cell growth (e.g., protease inhibitors, immunosuppressants, anti-cytokine therapies) within 30 days prior to index procedure or intended for use during any time after implantation through 12 months post-index procedure.
- Patient with an infection requiring antibiotic therapy
- Known allergy to Nitinol (for adjunctive self-expanding covered metallic stent procedure)
- Current participation in another investigational drug or device study
- Patient is a prisoner
- If in the opinion of the investigator, the patient requires pain management (potentially opioid medications) as a result of study participation, the patient is at an unreasonable risk of addiction. This decision may be based upon medical or social history, personal situation, or the expected time course, length, and type of medication use.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Shari Barnett, RRT,CCRP,PMP, 734-936-4561, shbailey@med.umich.edu
Andrew Chang, MD
- Recruiting
Keck Medical Center of University of Southern California
Los Angeles, California, 90033
Stephanie Varela, 323-442-6252, Stephanie.Varela@med.usc.edu
John Lipham, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Karlyn Pierson, MAN.RN.CCRP, 507-538-1960, pierson.karlyn@mayo.edu
Dennis Wigle, MD
About this study
Cellspan™ Esophageal Implant-Adult (CEI)
The CEI is a combination product consisting of an engineered synthetic scaffold (device constituent) seeded and cultured with the patient's adipose derived mesenchymal stem cells (biologic constituent), intended to stimulate regeneration of a structurally intact, living biologic esophageal conduit, in patients requiring full circumferential esophageal reconstruction up to 6 cm segment in length.
Read more
This is a dual arm, unblinded, multicenter, prospective first-in-human (FIH) feasibility study to be performed at a maximum of 5 centers in the United States with a maximum of 10 subjects in total. All subjects will be followed for a minimum of 2 years post-implant surgery.
Since this is an FIH experience, the study will utilize an independent Data Monitoring Committee (DMC) to evaluate safety on a continuous basis to mitigate any safety risks to subjects. A sentinel approach to enrollment of subjects shall be guided by the DMC review of cases.
- Conditions
- Esophageal Diseases
- Being tested
- CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus, CEI Extra-Thoracic Subdermal Surgical Implantation - Cellspan™ Esophageal Implant-Adult (CEI) in patients that have had a previous partial esophagectomy
- Keywords
- Esophagus, Esophagectomy, Tissue Engineering, Organ Regeneration, Regenerative Medicine, Cell Therapy, Dual Arm, Unblinded, Multicenter, FIH, CEI
- Medical subject headings
- Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagusCombination product
The CEI will be surgically implanted using standard thoracotomy techniques for esophageal reconstruction. Day 0 procedures include: a short segment esophageal resection up to 6 cm, CEI implantation with end-to-end anastomosis, placement of a covered metallic stent, securing the stent with sutures, measuring and recording the stent position, placing draining catheters, inserting a dual lumen gastric-jejunal feeding tube, and conducting hematology and serum tests. A baseline CT/MRI scan will be performed post-surgery to check the anastomotic sites and stent placement.
CEI Extra-Thoracic Subdermal Surgical Implantation - Cellspan™ Esophageal Implant-Adult (CEI) in patients that have had a previous partial esophagectomyCombination product
For CEI grafts extending the upper esophagus from the neck ostomy, the patient is positioned supine to expose the left neck and upper chest. A neck incision is made medial to the sternocleidomastoid muscle. The distal esophagus at the cervical spit fistula is freed and mobilized. The CEI is connected to the mobilized esophageal segment with absorbable sutures. Photos document the new spit fistula length post-graft. A new spit fistula tunnel is created on the anterior chest wall, preserving skin and tissue. A covered metallic stent is placed endoscopically through the spit fistula into the CEI, secured with sutures. Pre-surgery tests include hematology, serum chemistry, urinalysis, and CRP, with CRP checked on Days 3 and 5 post-surgery. A CT or MRI scan is done on days 3-7 post-surgery to establish a baseline for tissue deposition analysis around the CEI.
| Study group | Role | What they receive |
|---|---|---|
| Short Segment Esophageal Replacement in patients requiring a full reconstruction of the esophagus | Experimental | Not described Receives: Combination Product: CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus |
| Short Segment Esophageal Replacement in patients that have had a previous partial esophagectomy | Experimental | Not described Receives: Combination Product: CEI Extra-Thoracic Subdermal Surgical Implantation - Cellspan™ Esophageal Implant-Adult (CEI) in patients that have had a previous partial esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: The number of patients who develop continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation.
The number of patients who develops continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation, prior to or at Month 3 visit (Day 77 ±10) following implantation.
Measured: Month 3
All Cohorts: The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
Measured: 42 days
All Cohorts: The number of patients within the first 42 days that do not require a fall back emergency esophagectomy procedure
The number of patients within the first 42 days that do not require a fall back emergency esophagectomy procedure (gastric pull-up, colonic interposition, or other surgical reconstruction).
Measured: 42 days
All Cohorts: Number of participants experiencing death within 30 days of index procedure
Number of participants experiencing death within 30 days of index procedure
Measured: Within 30 days
Cohort 2: The number of patients with maturation of the CEI graft under the dermal layer followed by mobilization and connection to the distal esophagus within the thoracic cavity to form a continuous biologic neo-conduit based on endoscopic evaluation
The number of patients with maturation of the CEI graft under the dermal layer followed by mobilization and connection to the distal esophagus within the thoracic cavity to form a continuous biologic neo-conduit based on endoscopic evaluation
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start13 Jul 2023
- Primary completion18 May 2029 (estimated)
- Study completion16 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal DiseasesStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Apparatus Regenerative Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877300
- Sponsor's protocol ID
- BSTG-CEI-101
- Status last verified
- Oct 2025
- First submitted
- 5 May 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
- ClinicalTrials.gov ID
- NCT05877300
- Acronym / sponsor ID
- BSTG-CEI-101
- Conditions
- Esophageal Diseases
- Keywords
- Esophagus, Esophagectomy, Tissue Engineering, Organ Regeneration, Regenerative Medicine, Cell Therapy, Dual Arm, Unblinded
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Harvard Apparatus Regenerative Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 18 May 2029 (estimated)
- Study completion
- 16 Oct 2030 (estimated)
- First posted
- 26 May 2023 (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.
Cellspan™ Esophageal Implant-Adult (CEI)
The CEI is a combination product consisting of an engineered synthetic scaffold (device constituent) seeded and cultured with the patient's adipose derived mesenchymal stem cells (biologic constituent), intended to stimulate regeneration of a structurally intact, living biologic esophageal conduit, in patients requiring full circumferential esophageal reconstruction up to 6 cm segment in length.
This is a dual arm, unblinded, multicenter, prospective first-in-human (FIH) feasibility study to be performed at a maximum of 5 centers in the United States with a maximum of 10 subjects in total. All subjects will be followed for a minimum of 2 years post-implant surgery.
Since this is an FIH experience, the study will utilize an independent Data Monitoring Committee (DMC) to evaluate safety on a continuous basis to mitigate any safety risks to subjects. A sentinel approach to enrollment of subjects shall be guided by the DMC review of cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Segment Esophageal Replacement in patients requiring a full reconstruction of the esophagus | Experimental | Combination Product: CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus |
| Short Segment Esophageal Replacement in patients that have had a previous partial esophagectomy | Experimental | Combination Product: CEI Extra-Thoracic Subdermal Surgical Implantation - Cellspan™ Esophageal Implant-Adult (CEI) in patients that have had a previous partial esophagectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Subject ≥18 years of age
- The patient has medical conditions requiring esophageal reconstruction, such as, but not limited to:
- The patient must have failed at least 3 previous treatment modalities to correct the medical esophageal condition (a-d).
- The patient must be a surgical candidate for a short segment esophageal reconstruction (≤6 cm full circumferential segmental excision)
- The location of the esophageal segment for surgical resection is within the thoracic cavity, defined as, above the diaphragm and at least 4 cm below the larynx.
Key exclusion criteria (23 listed)
- Subject requires or undergoes an esophageal segmental excision >6 cm in length
- Esophageal segment extends below the diaphragm or <4 cm below larynx
- Pre-existing implants/structures adjacent to target surgical location for implant that could cause abrasion of the scaffold/regenerated tissue (e.g., pacemaker lead, vascular clips, vascular grafts).
- Known clinical contraindication that would obfuscate the use of the covered metallic stent to be used as an adjunct to the procedure
- Post ablation stricture for Barrett's esophagus treated less than 1 year prior to planned procedure
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 |
|---|---|---|
| CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagusThe CEI will be surgically implanted using standard thoracotomy techniques for esophageal reconstruction. Day 0 procedures include: a short segment esophageal resection up to 6 cm, CEI implantation with end-to-end anastomosis, placement of a covered metallic stent, securing the stent with sutures, measuring and recording the stent position, placing draining catheters, inserting a dual lumen gastric-jejunal feeding tube, and conducting hematology and serum tests. A baseline CT/MRI scan will be performed post-surgery to check the anastomotic sites and stent placement. | Combination product | Short Segment Esophageal Replacement in patients requiring a full reconstruction of the esophagus |
| CEI Extra-Thoracic Subdermal Surgical Implantation - Cellspan™ Esophageal Implant-Adult (CEI) in patients that have had a previous partial esophagectomyFor CEI grafts extending the upper esophagus from the neck ostomy, the patient is positioned supine to expose the left neck and upper chest. A neck incision is made medial to the sternocleidomastoid muscle. The distal esophagus at the cervical spit fistula is freed and mobilized. The CEI is connected to the mobilized esophageal segment with absorbable sutures. Photos document the new spit fistula length post-graft. A new spit fistula tunnel is created on the anterior chest wall, preserving skin and tissue. A covered metallic stent is placed endoscopically through the spit fistula into the CEI, secured with sutures. Pre-surgery tests include hematology, serum chemistry, urinalysis, and CRP, with CRP checked on Days 3 and 5 post-surgery. A CT or MRI scan is done on days 3-7 post-surgery to establish a baseline for tissue deposition analysis around the CEI. | Combination product | Short Segment Esophageal Replacement in patients that have had a previous partial esophagectomy |
Primary outcome
Cohort 1: The number of patients who develop continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation.
Time frame: Month 3
The number of patients who develops continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation, prior to or at Month 3 visit (Day 77 ±10) following implantation.
All Cohorts: The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
Time frame: 42 days
The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
All Cohorts: The number of patients within the first 42 days that do not require a fall back emergency esophagectomy procedure
Time frame: 42 days
The number of patients within the first 42 days that do not require a fall back emergency esophagectomy procedure (gastric pull-up, colonic interposition, or other surgical reconstruction).
All Cohorts: Number of participants experiencing death within 30 days of index procedure
Time frame: Within 30 days
Number of participants experiencing death within 30 days of index procedure
Cohort 2: The number of patients with maturation of the CEI graft under the dermal layer followed by mobilization and connection to the distal esophagus within the thoracic cavity to form a continuous biologic neo-conduit based on endoscopic evaluation
Time frame: Month 3
The number of patients with maturation of the CEI graft under the dermal layer followed by mobilization and connection to the distal esophagus within the thoracic cavity to form a continuous biologic neo-conduit based on endoscopic evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus and CEI Extra-Thoracic Subdermal Surgical Implantation - Cellspan™ Esophageal Implant-Adult (CEI) in patients that have had a previous partial esophagectomy in people with Esophageal Diseases, run by Harvard Apparatus Regenerative Technology, Inc. at 3 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 26 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shunfu Hu, Phd. (774.233.7341, shu@hregen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: The number of patients who develop continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation. (time frame: Month 3). The study lists 5 primary outcomes in all. 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 3 Sep 2026.