Umbilical Cord of Normal LaborNCT05093725
CD49 in Optimization The Cologenicity of Mesenchymal Stem Cell Culture Passage
An observational study of Umbilical Cord of Normal Labor, run by Sohag University at 1 site in Egypt.
Trial summary
Human mesenchymal stem cells (MSCs) due to their regenerative and immunomodulatory properties are widely used for the treatment of bone and cartilage damage, cardiovascular, gastrointestinal, autoimmune, neurodegenerative diseases and cancer .It is shown that the use of MSCs in therapy is safe and can be effective .In… Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord of Normal Labor
- What is being tested?
- flow cytomery
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2021to Jun 2022
- 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 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: taking umbilical cord of normally labored babies
Who may be able to join
- normal babies delivered by normal labor
Who cannot join
- diseased or congenital anomalies
Trial locations and contacts
1 site in 1 country.
Hasnaa A Abo-elwafa contact
About this study
Human mesenchymal stem cells (MSCs) due to their regenerative and immunomodulatory properties are widely used for the treatment of bone and cartilage damage, cardiovascular, gastrointestinal, autoimmune, neurodegenerative diseases and cancer .It is shown that the use of MSCs in therapy is safe and can be effective .In 2006, the International Society for Cellular Therapy (ISCT) proposed the minimal criteria to define human MSCs. First, MSCs must be plastic-adherent when maintained in the standard culture conditions. Second MSCs must express CD105, CD73 and CD90, and lack expression of CD45, CD34, CD14 or CD11b, CD79a or CD19 and HLA-DR surface molecules.
- Conditions
- Umbilical Cord of Normal Labor
- Being tested
- flow cytomery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flow cytomeryDevice
take sample of Wharton jelly and culturing it to know the best time for mesenchymal stem cell growth
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation the best passage of MSC culture by CD49 surface marker
evaluation the best passage of MSC culture by CD49 surface marker
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Umbilical Cord of Normal LaborStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samia samir shawky, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093725
- Sponsor's protocol ID
- Soh-med-21-10-01
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lv FJ, Tuan RS, Cheung KM, Leung VY. Concise review: the surface markers and identity of human mesenchymal stem cells. Stem Cells. 2014 Jun;32(6):1408-19. doi: 10.1002/stem.1681.
PubMed 24578244Madrigal M, Rao KS, Riordan NH. A review of therapeutic effects of mesenchymal stem cell secretions and induction of secretory modification by different culture methods. J Transl Med. 2014 Oct 11;12:260. doi: 10.1186/s12967-014-0260-8.
PubMed 25304688
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD49 in Optimization The Cologenicity of Mesenchymal Stem Cell Culture Passage
- ClinicalTrials.gov ID
- NCT05093725
- Acronym / sponsor ID
- Soh-med-21-10-01
- Conditions
- Umbilical Cord of Normal Labor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 26 Oct 2021 (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.
Human mesenchymal stem cells (MSCs) due to their regenerative and immunomodulatory properties are widely used for the treatment of bone and cartilage damage, cardiovascular, gastrointestinal, autoimmune, neurodegenerative diseases and cancer .It is shown that the use of MSCs in therapy is safe and can be effective .In 2006, the International Society for Cellular Therapy (ISCT) proposed the minimal criteria to define human MSCs. First, MSCs must be plastic-adherent when maintained in the standard culture conditions. Second MSCs must express CD105, CD73 and CD90, and lack expression of CD45, CD34, CD14 or CD11b, CD79a or CD19 and HLA-DR surface molecules.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- taking umbilical cord of normally labored babies
Key inclusion criteria (1 listed)
- normal babies delivered by normal labor
Key exclusion criteria (1 listed)
- diseased or congenital anomalies
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 |
|---|---|---|
| flow cytomerytake sample of Wharton jelly and culturing it to know the best time for mesenchymal stem cell growth | Device | – |
Primary outcome
evaluation the best passage of MSC culture by CD49 surface marker
Time frame: 7 months
evaluation the best passage of MSC culture by CD49 surface marker
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Background: PubMed 24578244Lv FJ, Tuan RS, Cheung KM, Leung VY. Concise review: the surface markers and identity of human mesenchymal stem cells. Stem Cells. 2014 Jun;32(6):1408-19. doi: 10.1002/stem.1681.
- Background: PubMed 25304688Madrigal M, Rao KS, Riordan NH. A review of therapeutic effects of mesenchymal stem cell secretions and induction of secretory modification by different culture methods. J Transl Med. 2014 Oct 11;12:260. doi: 10.1186/s12967-014-0260-8.
- Individual participant dataSharing planned: Yes
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.
Hasnaa A Abo-elwafa contact
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 Umbilical Cord of Normal Labor, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Oct 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact samia s shawky, resident (01280055734, samya_dematri@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation the best passage of MSC culture by CD49 surface marker (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05093725, which also lists 2 linked publications.
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 26 Oct 2021.