Adypose Mesenchimal Stem CellEarly Phase 1NCT04889963
Regeneration of Posterior Cruciate Ligament Injury Using Hypoxic Conditioned Allogenic Adipose Mesenchymal Stem Cell and Condition Medium
A Early Phase 1 study testing adypose mesenchymal conditioned medium and ligament derived conditioned medium in people with Adypose Mesenchimal Stem Cell and Ligament Rupture, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
Transplantation of Allogenic Adipose Mesenchimal Stem cell in hypoxic cultur condition with Ligament- derived conitioned medium can enhance regeneration of posterior cruciate ligament rupture Read more about this study
- Who is it for?
- Ages 2 to 12 months, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adypose Mesenchimal Stem Cell, Ligament Rupture, Ligament Derived Conditined Medium
- What is being tested?
- adypose mesenchymal conditioned medium and ligament derived conditioned medium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2021to 30 Jun 2021
- Phase
- Early Phase 1
- 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 2 to 12 months
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- white male new zealand rabbit
- weight 2500 - 3000 gram
Who cannot join
- have no disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Sholahuddin Rhatomy
Sleman, Special Region of Yogyakarta, 55571
sholahuddin rhatomy, MD, +62 274 588688 ext. 17225, rhatomy.s@gmail.com
About this study
Official title: Regeneration of Posterior Cruciate Ligament Injury Using Hypoxia Conditioned Allogenic Adipose Mesenchymal Stem Cell (AdMSC) and Ligament Derived Condition Medium (Secretome)
Transplantation of Allogenic Adipose Mesenchimal Stem cell in hypoxic cultur condition with Ligament- derived conitioned medium can enhance regeneration of posterior cruciate ligament rupture
Read the detailed description
this study is in vivo study to prove effect of transplantation of Allogenic Adipose Mesenchimal Stem cell in hypoxic cultur condition with Ligament- derived conitioned medium in regeneration of posterior cruciate ligament rupture
- Being tested
- adypose mesenchymal conditioned medium and ligament derived conditioned medium
- Keywords
- adypose mesenchimal stem cell hypoxic culture conditioned, Ligament Rupture, ligament derived conditined medium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adypose mesenchymal conditioned medium and ligament derived conditioned mediumBiological
rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture and ligament derived conditioned medium
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | rabbit with posterior cruciate ligament rupture and treated with fibrin glue (sacffold) Receives: Biological: adypose mesenchymal conditioned medium and ligament derived conditioned medium |
| conditioned medium group | Active comparator | rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with ligament derived conditioned medium Receives: Biological: adypose mesenchymal conditioned medium and ligament derived conditioned medium |
| stem cells group | Active comparator | rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture condition Receives: Biological: adypose mesenchymal conditioned medium and ligament derived conditioned medium |
| composite group | Experimental | rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture condition and ligament derived conditioned medium Receives: Biological: adypose mesenchymal conditioned medium and ligament derived conditioned medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
tensile strength of posterior cruciate ligament
measurement of tensile strength of posterior cruciate ligament
Measured: 6 weeks
Thrombosite of Growth Factor - beta 1
measurement value of Thrombosite Growth Factor - beta 1
Measured: 6 weeks
basic fibroblast of growth factor
measurement value of basic fibroblast of growth factor
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adypose Mesenchimal Stem CellStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sholahuddin Rhatomy, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889963
- Sponsor's protocol ID
- STEMCELL-LIGAMENTREGENERATION
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regeneration of Posterior Cruciate Ligament Injury Using Hypoxia Conditioned Allogenic Adipose Mesenchymal Stem Cell (AdMSC) and Ligament Derived Condition Medium (Secretome)
- ClinicalTrials.gov ID
- NCT04889963
- Acronym / sponsor ID
- STEMCELL-LIGAMENTREGENERATION
- Keywords
- adypose mesenchimal stem cell hypoxic culture conditioned, Ligament Rupture, ligament derived conditined medium
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 17 May 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.
Transplantation of Allogenic Adipose Mesenchimal Stem cell in hypoxic cultur condition with Ligament- derived conitioned medium can enhance regeneration of posterior cruciate ligament rupture
Detailed description
this study is in vivo study to prove effect of transplantation of Allogenic Adipose Mesenchimal Stem cell in hypoxic cultur condition with Ligament- derived conitioned medium in regeneration of posterior cruciate ligament rupture
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Biological: adypose mesenchymal conditioned medium and ligament derived conditioned mediumrabbit with posterior cruciate ligament rupture and treated with fibrin glue (sacffold) |
| conditioned medium group | Active comparator | Biological: adypose mesenchymal conditioned medium and ligament derived conditioned mediumrabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with ligament derived conditioned medium |
| stem cells group | Active comparator | Biological: adypose mesenchymal conditioned medium and ligament derived conditioned mediumrabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture condition |
| composite group | Experimental | Biological: adypose mesenchymal conditioned medium and ligament derived conditioned mediumrabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture condition and ligament derived conditioned medium |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- white male new zealand rabbit
- weight 2500 - 3000 gram
Key exclusion criteria (1 listed)
- have no 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 |
|---|---|---|
| adypose mesenchymal conditioned medium and ligament derived conditioned mediumrabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture and ligament derived conditioned medium | Biological | composite group, conditioned medium group, control group, stem cells group |
Primary outcome
tensile strength of posterior cruciate ligament
Time frame: 6 weeks
measurement of tensile strength of posterior cruciate ligament
Thrombosite of Growth Factor - beta 1
Time frame: 6 weeks
measurement value of Thrombosite Growth Factor - beta 1
basic fibroblast of growth factor
Time frame: 6 weeks
measurement value of basic fibroblast of growth factor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing adypose mesenchymal conditioned medium and ligament derived conditioned medium in people with Adypose Mesenchimal Stem Cell and Ligament Rupture, run by Gadjah Mada University at 1 site in Indonesia.
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 2 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 17 May 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 sholahuddin rhatomy, MD (+62 274 588688 ext. 17225, rhatomy.s@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tensile strength of posterior cruciate ligament (time frame: 6 weeks). The study lists 3 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 17 May 2021.