Kienböck's DiseasePhase 1NCT02646007
Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation(BM-MSC) for Kienbock's Disease
A Phase 1 study testing BM-MSC transplantation in people with Kienböck's Disease, run by Royan Institute at 1 site in Iran.
Trial summary
Kienböck's disease is characterized by avascular necrosis of the lunate wrist bone, which is usually progressive without treatment. Cell therapy is useful in treatment of degenerated bone and mesenchymal stromal/stem cells are the best candidates for this kind of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kienböck's Disease
- What is being tested?
- BM-MSC transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Nov 2015to Dec 2018
- 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
- Kienböck's disease without response to conservative treatment (physical and medical) for over 6 months
- Both genders
- Visual Analogue Scale of 4 or higher
- Hematological and biochemical analysis with no significant alterations that contraindicates intervention
- The patient is able to understand the nature of the study
- Informed written consent of the patient
Who cannot join
- Age over 65 or under 18 or legally dependent
- Infection signs or positive serology for HIV, hepatitis and syphilis
- Allergy to gentamicin, or to bovine, cattle or horse serum
- Pregnancy or lactating
- Pregnancy or breast-feeding
- Neoplasia
Show all 9Show fewer
- Immunosuppression
- Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study
- Other conditions that may, according to medical criteria, discourage participation in the study
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Royan Institute
Tehran
Nasser Aghdami, MD,PhD, (+98)23562000 ext. 516, nasser.aghdami@royaninstitute.org
Leila Arab, MD, (+98)23562000 ext. 414, Leara91@gmail.com
About this study
Official title: Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation for Human Avascular Necrosis of the Lunate Bone of the Wrist (Kienbock's Disease)
Kienböck's disease is characterized by avascular necrosis of the lunate wrist bone, which is usually progressive without treatment.
Cell therapy is useful in treatment of degenerated bone and mesenchymal stromal/stem cells are the best candidates for this kind of treatment.
Read more
This study examined lunate core decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal cells for Its treatment potential.
Bone decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal/stem cell will be done in 30 patients with Kienböck disease.
The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.
The Spss(v16) software will be used for data analysis.
Read the detailed description
Kienböck's disease is characterized by avascular necrosis of the lunate wrist There is probably no single cause of avascular necrosis of the lunate. Its origin may involve multiple factors, such as the blood supply (arteries), the blood drainage (veins), and skeletal variations.
Current treatments are: at the early phase only observation. In the more advanced phases surgical techniques such as bone decompression.
A potential therapeutic strategy would be cell therapy, A source of such cells with a regenerative potential could be mesenchymal stem cells (MSCs).
The investigators will evaluate safety and efficacy of implantation of autologous BM-MSC (bone marrow-derived mesenchymal stromal cell) in 30 patients with Kienböck's disease in combination with bone decompression surgery. These patients will be followed up and data will be analyzed with spss(v16).
- Conditions
- Kienböck's Disease
- Being tested
- BM-MSC transplantation
- Keywords
- Autologous Cell therapy Kienböck's disease, bone marrow derived mesenchymal stromal/stem cell
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM-MSC transplantationBiological
Transplantation of bone marrow derived mesenchymal stem/ stromal cells in combination with bone decompression surgery in Kienböck's disease.
| Study group | Role | What they receive |
|---|---|---|
| BM-MSC | Experimental | Bone marrow derived mesenchymal stromal/stem cells injection during decompressive surgery in patients with Kienböck's disease. Receives: Biological: BM-MSC transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
The pain reduction at least 3 months after BM-MSC transplantation cells in combination with bone decompression.
Measured: 3months
Bone density
The improvement of bone density at least 3months after BM-MSC transplantation in MRI.
Measured: 3 months
Secondary outcomes (3)
Quality of life evaluated by Visual Analogue Score (VAS)
Improvement of quality of life inpatients after at least 3months of BM-MSC transplantation that is evaluated by Visual Analogue Score (VAS). The patients depends on their severity of the pain during daily activity choose a score between 1-10. The score will be saved in score sheets.
Measured: 3 months
Infection: Presence of any sign or symptoms of infection
presence of any sign or symptoms of infection in site of surgery during 1 week.
Measured: 1week
Cyst formation: Presence of any cyst or mass formation
presence of any cyst or mass formation at least 3 months after BM-MSC transplantation with surgery.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
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 Kienböck's DiseaseStudies 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
- 30 participants (estimated)
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 department of Regenerative Medicine & Cell therapy center, Royan InstituteHamidreza Mehrpour, MD, Study director, Tehran university of medical science, department of orthopedic surgeryMohsen Emadedin, MD, Principal investigator, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.Narges Labibzadeh, MD, Principal investigator, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646007
- Sponsor's protocol ID
- Royan-Bone-014
- Status last verified
- Jul 2016
- First submitted
- 3 Dec 2015
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sadri B, Labibzadeh N, Mirmorsali L, Ebrahimi M, Bagherifard A, Arab L, Aghdami N, Madani H, Beheshti Maal A, Karimi S, Mehrpour SR, Emadedin M, Vosough M. Local Transplantation of Mesenchymal Stromal Cells Is Safe and Could Alleviate Kienbock Disease's Complications: A Clinical Trial Study. Cell J. 2024 Sep 11;26(7):446-453. doi: 10.22074/cellj.2024.2028891.1572.
PubMed 39290122
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation for Human Avascular Necrosis of the Lunate Bone of the Wrist (Kienbock's Disease)
- ClinicalTrials.gov ID
- NCT02646007
- Acronym / sponsor ID
- Royan-Bone-014
- Conditions
- Kienböck's Disease
- Keywords
- Autologous Cell therapy Kienböck's disease, bone marrow derived mesenchymal stromal/stem cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Nov 2015
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Jan 2016 (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.
Kienböck's disease is characterized by avascular necrosis of the lunate wrist bone, which is usually progressive without treatment.
Cell therapy is useful in treatment of degenerated bone and mesenchymal stromal/stem cells are the best candidates for this kind of treatment.
This study examined lunate core decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal cells for Its treatment potential.
Bone decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal/stem cell will be done in 30 patients with Kienböck disease.
The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.
The Spss(v16) software will be used for data analysis.
Detailed description
Kienböck's disease is characterized by avascular necrosis of the lunate wrist There is probably no single cause of avascular necrosis of the lunate. Its origin may involve multiple factors, such as the blood supply (arteries), the blood drainage (veins), and skeletal variations.
Current treatments are: at the early phase only observation. In the more advanced phases surgical techniques such as bone decompression.
A potential therapeutic strategy would be cell therapy, A source of such cells with a regenerative potential could be mesenchymal stem cells (MSCs).
The investigators will evaluate safety and efficacy of implantation of autologous BM-MSC (bone marrow-derived mesenchymal stromal cell) in 30 patients with Kienböck's disease in combination with bone decompression surgery. These patients will be followed up and data will be analyzed with spss(v16).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BM-MSC | Experimental | Biological: BM-MSC transplantationBone marrow derived mesenchymal stromal/stem cells injection during decompressive surgery in patients with Kienböck's disease. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Kienböck's disease without response to conservative treatment (physical and medical) for over 6 months
- Both genders
- Visual Analogue Scale of 4 or higher
- Hematological and biochemical analysis with no significant alterations that contraindicates intervention
- The patient is able to understand the nature of the study
Key exclusion criteria (9 listed)
- Age over 65 or under 18 or legally dependent
- Infection signs or positive serology for HIV, hepatitis and syphilis
- Allergy to gentamicin, or to bovine, cattle or horse serum
- Pregnancy or lactating
- Pregnancy or breast-feeding
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 |
|---|---|---|
| BM-MSC transplantationTransplantation of bone marrow derived mesenchymal stem/ stromal cells in combination with bone decompression surgery in Kienböck's disease. | Biological | BM-MSC |
Primary outcome
Pain
Time frame: 3months
The pain reduction at least 3 months after BM-MSC transplantation cells in combination with bone decompression.
Bone density
Time frame: 3 months
The improvement of bone density at least 3months after BM-MSC transplantation in MRI.
3 secondary outcomes
Quality of life evaluated by Visual Analogue Score (VAS)
Time frame: 3 months
Infection: Presence of any sign or symptoms of infection
Time frame: 1week
Cyst formation: Presence of any cyst or mass formation
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Derived from this study: PubMed 39290122Sadri B, Labibzadeh N, Mirmorsali L, Ebrahimi M, Bagherifard A, Arab L, Aghdami N, Madani H, Beheshti Maal A, Karimi S, Mehrpour SR, Emadedin M, Vosough M. Local Transplantation of Mesenchymal Stromal Cells Is Safe and Could Alleviate Kienbock Disease's Complications: A Clinical Trial Study. Cell J. 2024 Sep 11;26(7):446-453. doi: 10.22074/cellj.2024.2028891.1572.
- 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 department of Regenerative Medicine & Cell therapy center, Royan Institute
Hamidreza Mehrpour, MD study director
Tehran university of medical science, department of orthopedic surgery
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 BM-MSC transplantation in people with Kienböck's Disease, 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 6 inclusion and 9 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 20 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasser Aghdami, MD,PhD ((+98)23562000 ext. 516, nasser.aghdami@royaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 3months). The study lists 2 primary outcomes in all. 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 NCT02646007, 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 20 Jul 2016.