Evaluation of Clinical Efficacy of Autologous Adipose Tissue Derived ADSCSs in Treatment of Osteoarthritis (OA)
NCT05484856 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2022-08-02
Summary
Osteoarthritis (OA) is a degenerative disease of great morbidity in which therapies are typically palliative and only alleviate pain Mesenchymal stem cells ,adipose derived stromal cell are possible new chondroprotective regenerative treatment modalities.
Clinical Effectiveness after administration of adipose derived stromal cells along with platelet rich plasma was investigated in 140 patients having moderate to severe knee (stage 3 and 4)
Patients were evaluated and followed up for 2 year by subjective WOMAC score,six minute walking distance ,need of rescue medication Radiographic and MRI evaluation of joint space and cartilage thickness respectively
Conditions
- Osteoarthritis, Knee
Interventions
- BIOLOGICAL
-
Autologous adipose tissue derived stromal cells
autologous adipose tissue derived stromal cells is recovered as pellet after non enzymatic processing with sonication using ultrasound . This isolation process yielded an abundant population of Adipose stromal cells(ASCs) which have multipotent differentiation potential. Immunophenotype is a CD14-, CD29+, CD31-, CD34low/+, CD45-, CD73+ and CD105+ , the SVF represents the 50-70% in volume of a lipoaspirate specimen. The SVF hosts a heterogeneous cell population (110x103 cells/ml on average) comprising mainly CD105+ mesenchymal stem cells (MSC,2-- 20%), plus a wide number of CD34+ hematopoietic cells (40%)
Sponsors & Collaborators
-
Dr. Himanshu Bansal Foundation
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-16
- Primary Completion
- 2020-06-27
- Completion
- 2021-02-25
Countries
- India
Study Locations
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