Regenerative MedicineNCT07169838
Comparative Study of Perinatal Tissues for Clinical-Grade Mesenchymal Stem Cell Production and Cost-Effectiveness
An observational study of Regenerative Medicine and Stem Cell Banking, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This observational laboratory-based study was conducted to evaluate the clinical feasibility and cost-effectiveness of mesenchymal stem cell (MSC) production from perinatal medical waste, including umbilical cord, amniotic fluid, amniotic membrane, and placenta. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Regenerative Medicine, Stem Cell Banking, Perinatal Medical Waste
- What is being tested?
- Perinatal Tissue Collection
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population consisted of 160 healthy women with uncomplicated singleton pregnancies who delivered at term (≥37 weeks) at Kayseri City Hospital and Eskişehir Osmangazi University Hospital in Türkiye. Participants were aged between 18 and 45 years. Perinatal tissues, including amniotic fluid, amniotic membrane, umbilical cord, and placenta, were collected immediately after delivery as medical waste, with no additional intervention applied. All participants provided written informed consent.
Who may be able to join
- Female participants only
- Age between 18 and 45 years
- Singleton, uncomplicated term pregnancies (≥37 weeks of gestation)
- Delivery by either elective cesarean section or spontaneous vaginal birth
- Written informed consent obtained prior to sample collection
Who cannot join
- Presence of maternal infection at the time of delivery
- Known fetal malformations or chromosomal abnormalities
- Placental abnormalities (e.g., previa, abruption)
- Preterm labor (<37 weeks)
- Any maternal comorbidity that may compromise tissue quality (e.g., uncontrolled diabetes, hypertension, autoimmune disease)
- Inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing the Clinical Use of Perinatal Medical Waste: A Cost-Effectiveness Analysis of Fetal Stem Cell Production
This observational laboratory-based study was conducted to evaluate the clinical feasibility and cost-effectiveness of mesenchymal stem cell (MSC) production from perinatal medical waste, including umbilical cord, amniotic fluid, amniotic membrane, and placenta. A total of 160 tissue samples were collected from women delivering at term, and standardized protocols were applied for microbial sterility testing, MSC isolation, and cost analysis under Good Manufacturing Practice (GMP) conditions. The study compared MSC yield, contamination rates, and total processing costs across tissue types.
Read the detailed description
Perinatal medical waste, including the umbilical cord, amniotic fluid, amniotic membrane, and placenta, represents a promising and ethically acceptable source of mesenchymal stem cells (MSCs). Unlike bone marrow or adipose-derived MSCs, which require invasive procedures and are limited by donor morbidity and age-related decline, perinatal tissues are collected non-invasively at the time of delivery and are usually discarded. This study was designed to optimize the clinical use of such tissues by systematically comparing their feasibility for large-scale MSC banking under Good Manufacturing Practice (GMP) conditions.
This prospective observational study was conducted between January and June 2023 at Eskişehir Osmangazi University and Kayseri City Hospital. A total of 160 perinatal tissue samples were collected at term deliveries, including amniotic fluid, amniotic membrane, umbilical cord (Wharton's jelly), whole placenta, and placental fragments. Samples were transferred to the GMP-compliant Cellular Therapy and Stem Cell Production Center for laboratory processing. Microbial contamination was assessed using the automated BACTEC™ FX system. MSCs were isolated through tissue-specific protocols, expanded in culture to passage 3, and characterized based on morphology and adherence criteria established by the International Society for Cellular Therapy (ISCT).
Quantitative outcomes included viable MSC yield per sample, sterility outcomes, and proliferative capacity. A detailed cost-effectiveness analysis was also performed, incorporating procurement, transportation, storage, reagents, disposables, and technician labor. Costs were standardized per 1×10⁶ viable MSCs and expressed in U.S. dollars according to the average 2023 exchange rate.
- Conditions
- Regenerative Medicine, Stem Cell Banking, Perinatal Medical Waste, Umbilical Cord Stem Cells
- Being tested
- Perinatal Tissue Collection
- Keywords
- Mesenchymal Stem Cells, Perinatal Medical Waste, Umbilical Cord, Stem Cell Banking, Cost-Effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perinatal Tissue CollectionOther
Collection of perinatal medical waste (amniotic fluid, amniotic membrane, umbilical cord, placenta) at the time of term delivery for laboratory-based mesenchymal stem cell isolation and analysis. No therapeutic or interventional procedure was performed on participants.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women at term delivery providing perinatal tissue samples | Samples from this single cohort were divided into five tissue categories (amniotic fluid, amniotic membrane, umbilical cord, placental fragments, whole placenta) for comparative analysis of mesenchymal stem cell yield, sterility, and cost-effectiveness. Receives: Other: Perinatal Tissue Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viable Mesenchymal Stem Cell Yield
The average number of viable mesenchymal stem cells (MSCs) isolated per perinatal tissue sample (×10⁶ cells per sample).
Measured: Within 4 weeks after sample collection.
Secondary outcomes (3)
Microbial Contamination Rate
Proportion of perinatal tissue samples testing positive for microbial growth using the BACTEC™ FX system.
Measured: Within 48 hours after collection.
Cost per Million Viable MSCs
Average total cost (USD) of producing 1×10⁶ viable MSCs, including procurement, storage, isolation, and sterility testing.
Measured: Calculated during the study period (January-June 2023).
Population Doubling Time (PDT)
The proliferative capacity of MSCs at passage 3, calculated as population doubling time (hours).
Measured: Assessed at day 6-8 of culture expansion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Jan 2023
- Primary completion1 Jun 2023
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Copuroglu, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169838
- Sponsor's protocol ID
- KayseriCityHospital
- Other IDs
- 28/2023
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Clinical Use of Perinatal Medical Waste: A Cost-Effectiveness Analysis of Fetal Stem Cell Production
- ClinicalTrials.gov ID
- NCT07169838
- Acronym / sponsor ID
- KayseriCityHospital
- Conditions
- Regenerative Medicine, Stem Cell Banking, Perinatal Medical Waste, Umbilical Cord Stem Cells
- Keywords
- Mesenchymal Stem Cells, Perinatal Medical Waste, Umbilical Cord, Stem Cell Banking, Cost-Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 12 Sep 2025 (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.
This observational laboratory-based study was conducted to evaluate the clinical feasibility and cost-effectiveness of mesenchymal stem cell (MSC) production from perinatal medical waste, including umbilical cord, amniotic fluid, amniotic membrane, and placenta. A total of 160 tissue samples were collected from women delivering at term, and standardized protocols were applied for microbial sterility testing, MSC isolation, and cost analysis under Good Manufacturing Practice (GMP) conditions. The study compared MSC yield, contamination rates, and total processing costs across tissue types.
Detailed description
Perinatal medical waste, including the umbilical cord, amniotic fluid, amniotic membrane, and placenta, represents a promising and ethically acceptable source of mesenchymal stem cells (MSCs). Unlike bone marrow or adipose-derived MSCs, which require invasive procedures and are limited by donor morbidity and age-related decline, perinatal tissues are collected non-invasively at the time of delivery and are usually discarded. This study was designed to optimize the clinical use of such tissues by systematically comparing their feasibility for large-scale MSC banking under Good Manufacturing Practice (GMP) conditions.
This prospective observational study was conducted between January and June 2023 at Eskişehir Osmangazi University and Kayseri City Hospital. A total of 160 perinatal tissue samples were collected at term deliveries, including amniotic fluid, amniotic membrane, umbilical cord (Wharton's jelly), whole placenta, and placental fragments. Samples were transferred to the GMP-compliant Cellular Therapy and Stem Cell Production Center for laboratory processing. Microbial contamination was assessed using the automated BACTEC™ FX system. MSCs were isolated through tissue-specific protocols, expanded in culture to passage 3, and characterized based on morphology and adherence criteria established by the International Society for Cellular Therapy (ISCT).
Quantitative outcomes included viable MSC yield per sample, sterility outcomes, and proliferative capacity. A detailed cost-effectiveness analysis was also performed, incorporating procurement, transportation, storage, reagents, disposables, and technician labor. Costs were standardized per 1×10⁶ viable MSCs and expressed in U.S. dollars according to the average 2023 exchange rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women at term delivery providing perinatal tissue samples | – | Other: Perinatal Tissue CollectionSamples from this single cohort were divided into five tissue categories (amniotic fluid, amniotic membrane, umbilical cord, placental fragments, whole placenta) for comparative analysis of mesenchymal stem cell yield, sterility, and cost-effectiveness. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consisted of 160 healthy women with uncomplicated singleton pregnancies who delivered at term (≥37 weeks) at Kayseri City Hospital and Eskişehir Osmangazi University Hospital in Türkiye. Participants were aged between 18 and 45 years. Perinatal tissues, including amniotic fluid, amniotic membrane, umbilical cord, and placenta, were collected immediately after delivery as medical waste, with no additional intervention applied. All participants provided written informed consent.
Key inclusion criteria (5 listed)
- Female participants only
- Age between 18 and 45 years
- Singleton, uncomplicated term pregnancies (≥37 weeks of gestation)
- Delivery by either elective cesarean section or spontaneous vaginal birth
- Written informed consent obtained prior to sample collection
Key exclusion criteria (6 listed)
- Presence of maternal infection at the time of delivery
- Known fetal malformations or chromosomal abnormalities
- Placental abnormalities (e.g., previa, abruption)
- Preterm labor (<37 weeks)
- Any maternal comorbidity that may compromise tissue quality (e.g., uncontrolled diabetes, hypertension, autoimmune disease)
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 |
|---|---|---|
| Perinatal Tissue CollectionCollection of perinatal medical waste (amniotic fluid, amniotic membrane, umbilical cord, placenta) at the time of term delivery for laboratory-based mesenchymal stem cell isolation and analysis. No therapeutic or interventional procedure was performed on participants. | Other | Pregnant women at term delivery providing perinatal tissue samples |
Primary outcome
Viable Mesenchymal Stem Cell Yield
Time frame: Within 4 weeks after sample collection.
The average number of viable mesenchymal stem cells (MSCs) isolated per perinatal tissue sample (×10⁶ cells per sample).
3 secondary outcomes
Microbial Contamination Rate
Time frame: Within 48 hours after collection.
Cost per Million Viable MSCs
Time frame: Calculated during the study period (January-June 2023).
Population Doubling Time (PDT)
Time frame: Assessed at day 6-8 of culture expansion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regenerative Medicine and Stem Cell Banking, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viable Mesenchymal Stem Cell Yield (time frame: Within 4 weeks after sample collection.). 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 12 Sep 2025.