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Trial record 25 of 56 for:    stem cell arthritis AND bone marrow

Clinical Outcomes of Open Wedge High Tibial Osteotomy With Autologous Bone Marrow or Adipose-derived Stem Cell Therapy (HTOSC)

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ClinicalTrials.gov Identifier: NCT02642848
Recruitment Status : Unknown
Verified January 2016 by Dongsik Chae, Catholic Kwandong University.
Recruitment status was:  Recruiting
First Posted : December 30, 2015
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Dongsik Chae, Catholic Kwandong University

Brief Summary:
The purpose of this research is to confirm the efficacy of cartilage regeneration (or stem cell transplant) simultaneously performed with high tibial osteotomy. Furthermore, as conventional microfracture surgery on injured cartilage has a disadvantage of the replacement by fibrocartilage, this research intends to prove the excellence over the conventional therapy by proving a hyaline cartilage regeneration of injured cartilage by stem cell.

Condition or disease Intervention/treatment Phase
Osteoarthritis Genu Varum Procedure: HTO with microfracture Procedure: Transplantation of bone marrow stem cell Procedure: Transplantation of adipose derived stem cell Not Applicable

Detailed Description:
The prevalence rate of arthritis in medial knee joint is increasing with an increase in senile diseases and there are two main types of therapy: total knee replacement surgery and high tibial osteotomy. Generally, the elderly prefer total knee replacement surgery and younger people prefer high tibial osteotomy. High tibial osteotomy is a procedure to reduce pain and to prevent the progression of osteoarthritis by evenly dispersing excessive load on medial knee joint attributed to varus deformity on the overall knee joint through the correction of abnormal anatomical axis arising from degenerative changes in articular cartilage. The clinical outcomes of high tibial osteotomy are reported as favorable but this high tibial osteotomy has a limitation in terms of the regeneration of injured cartilage. Thus, a research to concurrently perform additional therapy for the regeneration of injured cartilage with the osteotomy was released. Microfracture surgery on injured cartilage, autologous chondrocyte implantation, autologous bone marrow injections and adipose derived stem cell injections are typical examples. However, there is not any solid proof for the excellence of concurrent therapy over a therapy using only the osteotomy in the regeneration of injured cartilage. Therefore, this research is designed to conduct a research to prove the excellence of the direct transplantation of stem cell into injured cartilage over the existing concurrent therapy in the regeneration of injured cartilage. Besides, this research intends to compare the cartilage regeneration capabilities of bone marrow and adipose-derived stem cell.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcomes of Open Wedge High Tibial Osteotomy With Autologous Bone Marrow or Adipose-derived Stem Cell Therapy
Study Start Date : June 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: HTO with micro fracture
High tibial osteotomy(HTO) with micro fracture is an common treatment for the correction of malalignment of the knee treating osteoarthritis.
Procedure: HTO with microfracture
High tibial osteotomy(HTO) with micro fracture on femoral condyle is an common treatment for the correction of malalignment of the knee treating osteoarthritis. Device: Tomofix

Experimental: HTO with bone marrow stem cell
High tibial osteotomy(HTO) with transplantation of autologous bone marrow cell concentrate using BMAC collecting from iliac bone.
Procedure: HTO with microfracture
High tibial osteotomy(HTO) with micro fracture on femoral condyle is an common treatment for the correction of malalignment of the knee treating osteoarthritis. Device: Tomofix

Procedure: Transplantation of bone marrow stem cell
Transplantation of autologous bone marrow cell concentrate using BMAC collecting from iliac bone. Bone marrow cell cell 6cc

Experimental: HTO with adipose derived stem cell
High tibial osteotomy(HTO) with autologous adipose-derived stromal vascular fraction transplantation using LipoSculptor collecting from abdominal fat tissue.
Procedure: HTO with microfracture
High tibial osteotomy(HTO) with micro fracture on femoral condyle is an common treatment for the correction of malalignment of the knee treating osteoarthritis. Device: Tomofix

Procedure: Transplantation of adipose derived stem cell
Transplantation of autologous adipose-derived stromal vascular fraction using LipoSculptor collecting from abdominal fat tissue. Adipose derived stem cell from abdominal fat tissue 3cc




Primary Outcome Measures :
  1. Knee score [ Time Frame: one year ]
  2. MRI [ Time Frame: One year ]
    Using MRI, evaluate cartilage conditions by ICRS grade

  3. Arthroscopic finding [ Time Frame: One year ]
    Using arthroscopy, evaluate degree of cartilage repair



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

15 or more to 65 years of age or younger Classification of degenerative arthritis: Kellgren-Lawrence grade I, III, III Arthritis lesion limited to medial knee joint Varus deformity of knee joint of 15 degrees or less BMI under 35

Exclusion Criteria:

More than 65 years of age Classification of degenerative arthritis: Kellgren-Lawrence grade IV Lesions of arthritis (Kellgren-Lawrence grade III, IV) found in lateral knee joint Varus deformity of knee joint more than 15 degrees BMI above 35 Operation history - Surgery of Microfracture and fracture, and ligament regeneration History of intraarticular injection of steroid and hyaluronic acid in the last 3 months


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642848


Contacts
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Contact: Dongsik Chae 82-32-290-3151 drchaeos@gmail.com
Contact: Jeong-min Shin 82-32-290-3158 kook4731@naver.com

Locations
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Korea, Republic of
International St. Mary's Hospital Recruiting
Incheon, Korea, Republic of, 22711
Contact: Jeong-min Shin    82-32-290-3158      
Sponsors and Collaborators
Dongsik Chae

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Responsible Party: Dongsik Chae, Assistant professor, Catholic Kwandong University
ClinicalTrials.gov Identifier: NCT02642848     History of Changes
Other Study ID Numbers: IS15OISI0021
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Osteoarthritis
Genu Varum
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bone Diseases