Evaluation of Clinical Efficacy of Autologous Adipose Tissue Derived ADSCSs in Treatment of Osteoarthritis (OA)

NCT05484856 | Completed Phase 1 DMC

• 1 other identifier: AAH/CLINICALTRIAL/01/2016
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

: stromal vascular fraction (SVF), adipose derived stromal cells, adipose tissue, connective tissue, osteoarthritis, therapy

Outcome Measures

Primary Outcomes (2)

• changes in womac score

  WOMAC, a widely used measure to assess patients' pain, joint mobility, and physical disability evaluates three dimensions, pain, stiffness, and physical function, with 5, 2, and 17 questions, respectively. The total maximum score is 96 and minimum, 0. the higher the worse.

  [Time Frame: baseline,1 month,3 months,6 months, and 1year18 months and 2 year

• changes in cartilage thickness as assessed on 1.5 T MRI

  Using the 1.5-T field strength with standard MRI acquisition protocols, MRI was performed of each joint individually in coronal, sagittal, and transverse planes. The maximum thickness of the cartilage at posterior,meniscal and patellar level measured at the midsagittal plane through the medial condyle was considered. The medial femoral cartilage of the affected knee was chosen for measurement

  baseline and at one year and 2 year

Secondary Outcomes (1)

• changes in joint space width

  baseline and at one year and 2 year

Study Arms (1)

Experimental

EXPERIMENTAL

Patients with Osteoarthritis A total of 140 patients ( May 2016 to june 2020) were treated with intra articular adipose derived stromal cells (ADSC)) also known as Stromal vascualr fraction administration

Biological: Autologous adipose tissue derived stromal cells

Interventions

Autologous adipose tissue derived stromal cells BIOLOGICAL

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%)

Experimental

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients who fulfilled the clinical and radiological criteria set by the American College of Rheumatology for the diagnosis of symptomatic primary knee OA

You may not qualify if:

• Evidence of secondary knee OA because of injury, inflammatory or metabolic rheumatic disease, or osteonecrosis;
• Prior intra-articular injection of hyaluronic acid (HA), including lavage and corticosteroids within the previous three months;
• Severe knee OA, with JSW \<1 mm, or surgery required on the evaluated knee in the year
• Patients with clinically significant systemic disease

Sponsors & Collaborators

• Dr. Himanshu Bansal Foundation: lead

Study Sites (1)

Anupam Hospital

Rudrapur, Uttarakhand, 263153, India

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Model Details: This is prospective, open label, single arm clinical study that will establish the safety and efficacy of adipose derived stromal cells in patients with osteoarthritis disease. Total 140 subjects were enrolled in the study. Each subject will receive intra-articular Autologous ADSC with PRP along with standard treatment for osteoarthritis disease.

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 2, 2022
• Study Start: May 16, 2016
• Primary Completion: June 27, 2020
• Study Completion: February 25, 2021
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: TO BE PUBLISHED BY MAY 2023
• Access Criteria: ANYONE

Locations

IN (1)