Leg Length InequalityPhase 1NCT01210950
Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation
A Phase 1 study testing cell and RPR injection in people with Leg Length Inequality, run by Royan Institute at 1 site in Iran.
Trial summary
Limb-length discrepancy can be due to many causes. These are divided into three groups: congenital (from birth), developmental (from a childhood disease or injury that slows or damages the growth plates), and posttraumatic (from a fracture that leads to shortening of the bone ends). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leg Length Inequality
- What is being tested?
- cell and RPR injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIran
- Study dates
- Sep 2009to Dec 2013
- Phase
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both gender
- patient with limb-length discrepancy
- Age:18-65
Who cannot join
- Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease
- Known allergic reaction to components of study treatment and/or study injection procedure
- Patients infected with hepatitis B,C or HIV
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Distraction Osteogenesis in Patients With Limb-length Discrepancy
Limb-length discrepancy can be due to many causes. These are divided into three groups: congenital (from birth), developmental (from a childhood disease or injury that slows or damages the growth plates), and posttraumatic (from a fracture that leads to shortening of the bone ends). There are three ways to equalize the limb-length discrepancy: use a shoe lift, shorten the long leg, lengthen the short leg. Most patients do not like wearing a lift greater than 2 cm (3/4 in). For discrepancies greater than 2 cm but less than 5 cm (2 in), shortening of the long leg can be considered, especially for tall persons. For growing children, this can be easily accomplished with a small, minimally invasive, uncomplicated procedure called epiphysiodesis.The investigators aim to evaluate if injection of bone marrow derived mesenchymal stem cells can shorten the treatment period by acceleration of bone regeneration during distraction osteogenesis.
Read the detailed description
Distraction osteogenesis has been widely utilized to treat leg length discrepancy, deformity, nonunion, osteomyelitis, and bone loss. It has been found that most difficult conditions can be resolved with this method. In this study the aim is to observe if mesenchymal stem cell transplantation can enhance new bone formation during distraction osteogenesis.Patients undergo bone distraction , and about 2-3 weeks after distraction mesenchymal stem cell are injected at the callus site. In the case of large bone gap, mesenchymal stem cells are seeded on bone matrix and then placed in the bone gap. Each patient is assessed at interval time of 1 month for 6 months post surgery by X-Ray and at month 6 post surgery by computed tomography(CT) scans.
- Conditions
- Leg Length Inequality
- Being tested
- cell and RPR injection
- Keywords
- distraction, osteogenesis, limb length discrepancy, callus
- Medical subject headings
- Leg Length Inequality, Callosities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell and RPR injectionBiological
Also called cell therapy
mesenchymal cells and Plasma reach Protein are injected to the callus center
| Study group | Role | What they receive |
|---|---|---|
| cell and RPR recepients | Experimental | mesenchymal cells and plasma reach protein are injected to the callus center of short limb Receives: Biological: cell and RPR injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of mesenchymal cell transplantation to decrease limb inequal
evaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening and decrease limb inequal
Measured: 6 months
Secondary outcomes (1)
improve life quality
mesenchymal cells transplantation improve patients life quality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg Length InequalityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, President of Royan InstituteMohammad reza Baghban Eslami Nejad, PhD, Study director, Board scientificMohssen Emadeddin, MD, Principal investigator, Orthopadic InvestigatorNasser Aghdami, MD,PhD, Principal investigator, Head of Regenerative center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210950
- Sponsor's protocol ID
- Royan-Bone-006
- Status last verified
- Apr 2008
- First submitted
- 25 Sep 2010
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Distraction Osteogenesis in Patients With Limb-length Discrepancy
- ClinicalTrials.gov ID
- NCT01210950
- Acronym / sponsor ID
- Royan-Bone-006
- Conditions
- Leg Length Inequality
- Keywords
- distraction, osteogenesis, limb length discrepancy, callus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Sep 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Sep 2010 (estimated)
- 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.
Limb-length discrepancy can be due to many causes. These are divided into three groups: congenital (from birth), developmental (from a childhood disease or injury that slows or damages the growth plates), and posttraumatic (from a fracture that leads to shortening of the bone ends). There are three ways to equalize the limb-length discrepancy: use a shoe lift, shorten the long leg, lengthen the short leg. Most patients do not like wearing a lift greater than 2 cm (3/4 in). For discrepancies greater than 2 cm but less than 5 cm (2 in), shortening of the long leg can be considered, especially for tall persons. For growing children, this can be easily accomplished with a small, minimally invasive, uncomplicated procedure called epiphysiodesis.The investigators aim to evaluate if injection of bone marrow derived mesenchymal stem cells can shorten the treatment period by acceleration of bone regeneration during distraction osteogenesis.
Detailed description
Distraction osteogenesis has been widely utilized to treat leg length discrepancy, deformity, nonunion, osteomyelitis, and bone loss. It has been found that most difficult conditions can be resolved with this method. In this study the aim is to observe if mesenchymal stem cell transplantation can enhance new bone formation during distraction osteogenesis.Patients undergo bone distraction , and about 2-3 weeks after distraction mesenchymal stem cell are injected at the callus site. In the case of large bone gap, mesenchymal stem cells are seeded on bone matrix and then placed in the bone gap. Each patient is assessed at interval time of 1 month for 6 months post surgery by X-Ray and at month 6 post surgery by computed tomography(CT) scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cell and RPR recepients | Experimental | Biological: cell and RPR injectionmesenchymal cells and plasma reach protein are injected to the callus center of short limb |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- both gender
- patient with limb-length discrepancy
- Age:18-65
Key exclusion criteria (4 listed)
- Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease
- Known allergic reaction to components of study treatment and/or study injection procedure
- Patients infected with hepatitis B,C or HIV
- pregnancy
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 |
|---|---|---|
| cell and RPR injectionAlso: cell therapymesenchymal cells and Plasma reach Protein are injected to the callus center | Biological | cell and RPR recepients |
Primary outcome
effect of mesenchymal cell transplantation to decrease limb inequal
Time frame: 6 months
evaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening and decrease limb inequal
1 secondary outcome
improve life quality
Time frame: 12 months
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 28 Apr 2014.
- Royan InstituteLink provided by the sponsor.
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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.
Hamid Gourabi, PhD study chair
President of Royan Institute
Mohammad reza Baghban Eslami Nejad, PhD study director
Board scientific
Mohssen Emadeddin, MD principal investigator
Orthopadic Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cell and RPR injection in people with Leg Length Inequality, run by Royan Institute at 1 site in Iran.
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 3 inclusion and 4 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 28 Apr 2014. 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 Iran. 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?
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?
effect of mesenchymal cell transplantation to decrease limb inequal (time frame: 6 months). 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 28 Apr 2014.