OsteoarthritisPhase 1NCT01436058
Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Ankle Joint Osteoartritis
A Phase 1 study testing mesenchymal stem cell in people with Osteoarthritis, run by Royan Institute at 1 site in Iran.
Trial summary
Ankle osteoarthritis is a joint condition which results from damage and loss of the cartilage in a joint. Treatment options for ankle osteoarthritis are usually aimed at controlling pain and limiting motion that provokes the pain. Nonsurgical treatment approaches are tried first. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- mesenchymal stem cell
- 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 2010to Sep 2011
- 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
- Osteoarthritis diagnosed by MRI
- End stage osteoarthritis candidate for total ankle replacement
Who cannot join
- Pregnancy or lactating
- Positive tests for HIV, HCV, HBV
- Active neurologic disorder
- End organ damage
- Uncontrolled endocrine disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Patients With Ankle Joint Osteoarteritis
Ankle osteoarthritis is a joint condition which results from damage and loss of the cartilage in a joint. Treatment options for ankle osteoarthritis are usually aimed at controlling pain and limiting motion that provokes the pain. Nonsurgical treatment approaches are tried first. If unsuccessful, surgical options are considered. Stem cell therapy is one of the therapeutic options that can repair the damaged cartilage. Bone marrow derived mesenchymal stem cells have showed the capacity of bone and cartilage regeneration.
Read the detailed description
In this clinical study the investigators aim to investigate the safety of intra-articular injection of cultured autologous bone marrow derived mesenchymal stem cells (BM-MSCs) to the ankle joint in patients with severe ankle osteoarthritis. Patients will undergo bone marrow aspiration and will receive cultured BM-MSCs one month later. Patients will be assessed clinically with scoring system (FAO, VAS, WOMAC) preoperatively as well as 2 and 6 months postoperative to measure pain reduction and joint function improvement. Paraclinical studies (X-Ray and MRI) will be performed before and 6 months after treatment.
- Conditions
- Osteoarthritis
- Being tested
- mesenchymal stem cell
- Keywords
- side effect, mesenchymal stem cell, ankle, osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cellBiological
Also called stem cell transplantation
intraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| stem cell recipient | Experimental | patients with ankle joint osteoarthritis Receives: Biological: mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
Evaluate Safety of intra-articular injection of autologous cultured mesenchymal stem cells in patients with ankle osteoarthritis (time frame : baseline, 2 months, 6 months)by filling the check list of side effects
Measured: 6 months
Secondary outcomes (3)
pain
evaluation the pain reduction in patients with ankle joint osteoarthritis after stem cell transplantation by filling the SF36
Measured: 6 months
physical function
evaluation the ability of patient to standing,walking,climb the steps after stem cell transplantation.
Measured: 6 months
defect
evaluation regeneration of ankle joint by serial MRI after stem cell transplantation based on changing the size of articular defect
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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, Head of Royan InstituteNasser Aghdami, MD,PhD, Study director, Head of Royan Cell therapy CenterMohsen Emadeddin, MD, Principal investigator, orthopedic scientists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436058
- Sponsor's protocol ID
- Royan-Bone-007
- Status last verified
- May 2010
- First submitted
- 14 Sep 2011
- Last updated
- 19 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Emadedin M, Ghorbani Liastani M, Fazeli R, Mohseni F, Moghadasali R, Mardpour S, Hosseini SE, Niknejadi M, Moeininia F, Aghahossein Fanni A, Baghban Eslaminejhad R, Vosough Dizaji A, Labibzadeh N, Mirazimi Bafghi A, Baharvand H, Aghdami N. Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. Arch Iran Med. 2015 Jun;18(6):336-44.
PubMed 26058927
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Patients With Ankle Joint Osteoarteritis
- ClinicalTrials.gov ID
- NCT01436058
- Acronym / sponsor ID
- Royan-Bone-007
- Conditions
- Osteoarthritis
- Keywords
- side effect, mesenchymal stem cell, ankle, osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Sep 2011 (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.
Ankle osteoarthritis is a joint condition which results from damage and loss of the cartilage in a joint. Treatment options for ankle osteoarthritis are usually aimed at controlling pain and limiting motion that provokes the pain. Nonsurgical treatment approaches are tried first. If unsuccessful, surgical options are considered. Stem cell therapy is one of the therapeutic options that can repair the damaged cartilage. Bone marrow derived mesenchymal stem cells have showed the capacity of bone and cartilage regeneration.
Detailed description
In this clinical study the investigators aim to investigate the safety of intra-articular injection of cultured autologous bone marrow derived mesenchymal stem cells (BM-MSCs) to the ankle joint in patients with severe ankle osteoarthritis. Patients will undergo bone marrow aspiration and will receive cultured BM-MSCs one month later. Patients will be assessed clinically with scoring system (FAO, VAS, WOMAC) preoperatively as well as 2 and 6 months postoperative to measure pain reduction and joint function improvement. Paraclinical studies (X-Ray and MRI) will be performed before and 6 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stem cell recipient | Experimental | Biological: mesenchymal stem cellpatients with ankle joint osteoarthritis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Osteoarthritis diagnosed by MRI
- End stage osteoarthritis candidate for total ankle replacement
Key exclusion criteria (5 listed)
- Pregnancy or lactating
- Positive tests for HIV, HCV, HBV
- Active neurologic disorder
- End organ damage
- Uncontrolled endocrine disorder
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 |
|---|---|---|
| mesenchymal stem cellAlso: stem cell transplantationintraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis | Biological | stem cell recipient |
Primary outcome
safety
Time frame: 6 months
Evaluate Safety of intra-articular injection of autologous cultured mesenchymal stem cells in patients with ankle osteoarthritis (time frame : baseline, 2 months, 6 months)by filling the check list of side effects
3 secondary outcomes
pain
Time frame: 6 months
physical function
Time frame: 6 months
defect
Time frame: 6 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 19 Sep 2011.
- Derived from this study: PubMed 26058927Emadedin M, Ghorbani Liastani M, Fazeli R, Mohseni F, Moghadasali R, Mardpour S, Hosseini SE, Niknejadi M, Moeininia F, Aghahossein Fanni A, Baghban Eslaminejhad R, Vosough Dizaji A, Labibzadeh N, Mirazimi Bafghi A, Baharvand H, Aghdami N. Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. Arch Iran Med. 2015 Jun;18(6):336-44.
- Related InfoLink 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
Head of Royan Institute
Nasser Aghdami, MD,PhD study director
Head of Royan Cell therapy Center
Mohsen Emadeddin, MD principal investigator
orthopedic scientists
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 mesenchymal stem cell in people with Osteoarthritis, 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 2 inclusion and 5 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 19 Sep 2011. 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?
safety (time frame: 6 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 NCT01436058, which also lists 1 linked publication.
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 19 Sep 2011.