Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Ankle Joint Osteoartritis
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| ClinicalTrials.gov Identifier: NCT01436058 |
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Recruitment Status :
Completed
First Posted : September 19, 2011
Last Update Posted : September 19, 2011
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Sponsor:
Royan Institute
Information provided by (Responsible Party):
Royan Institute
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | September 14, 2011 | |||||||||
| First Posted Date ICMJE | September 19, 2011 | |||||||||
| Last Update Posted Date | September 19, 2011 | |||||||||
| Study Start Date ICMJE | September 2010 | |||||||||
| Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Ankle Joint Osteoartritis | |||||||||
| Official Title ICMJE | Phase 1 Study of Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Patients With Ankle Joint Osteoarteritis | |||||||||
| Brief 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. 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 Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 1 | |||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis | |||||||||
| Intervention ICMJE | Biological: mesenchymal stem cell
intraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis
Other Name: stem cell transplantation
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| Study Arms ICMJE | Experimental: stem cell recipient
patients with ankle joint osteoarthritis
Intervention: Biological: mesenchymal stem cell
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| 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. doi: 015186/AIM.003. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
6 | |||||||||
| Original Actual Enrollment ICMJE | Same as current | |||||||||
| Actual Study Completion Date ICMJE | September 2011 | |||||||||
| Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Iran, Islamic Republic of | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01436058 | |||||||||
| Other Study ID Numbers ICMJE | Royan-Bone-007 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Royan Institute | |||||||||
| Study Sponsor ICMJE | Royan Institute | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Royan Institute | |||||||||
| Verification Date | May 2010 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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