Mesenchymal Stem Cells Enhanced With PRP Versus PRP In OA Knee

NCT01985633 | Unknown Phase 1 DMC

• 1 other identifier: Adi_MSC_PRP_OA_2013
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is one of the most common joint diseases.This disease commonly develops in the weight bearing joints of the lower limbs, such as the knee and hip joints. Osteoarthritis is considered a chronic degenerative disorder that is characterized by a loss of articular cartilage. Pathogenesis can involve all of the major articular tissues including cartilage, synovial membrane, subchondral bone and other connective tissues such as ligaments and tendons3. There is no effective therapy available today that alters the pathobiologic course of the disease.In view of vast role of platelet derived growth factors, mesenchymal cells and its safety, this prospective clinical trial is designed in an attempt to compare the efficacy of mesenchymal stem cells enhanced with platelet rich plasma in early stages of knee osteoarthritis.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; stem cells; Platelet gel; Functional outcome

Outcome Measures

Primary Outcomes (1)

• Pain relief

  Pain will be measured using Visual analogue scale (VAS)which consists of markings from 1 to 10.

  Participants will be followed upto an average of 6months.

Secondary Outcomes (1)

• Functional Outcome

  Participants will be followed upto an average of 6months.

Other Outcomes (1)

• Quantitative articular cartilage volume analysis

  Participants will be followed upto an average of 6months.

Study Arms (2)

Mesenchymal stem cell, PRP

EXPERIMENTAL

Twelve patients will be placed in supine position with knee in full extension and under full aseptic precautions 10 ml of Mesenchymal stem cell suspension and 8-10 ml of platelet rich plasma would be injected by lateral approach with an 18-20 G needle

Biological: Mesenchymal stem cell suspension; Biological: PRP

platelet rich plasma

ACTIVE COMPARATOR

About 100 ml of venous blood would be drawn with aseptic technique from the antecubital vein with an 18g needle , in order to avoid irritation and trauma to the platelets which are in a resting state. The blood would be collected in a 100 ml paediatric bag with CPDA(citrate phosphate dextrose adenine) as anti coagulant. A leucocyte filter will be also used to filter off the leucocytes. The blood will be then centrifuged for 15 min at 1300 rpm. This separates blood in to RBC( packed red blood cells) and platelet rich plasma. Next the PRP will be passed through a leucocyte filter to obtain leucocyte poor platelet rich plasma. 10 ml of PRP will be dispensed in a sterile syringe. The PRP would be used for injection.

Biological: PRP

Interventions

Mesenchymal stem cell suspension BIOLOGICAL

About 8-10ml of bone marrow would be aspirated under strict aseptic precautions, cell fractionationated with Ficoll sol,centrifuged at 1100rpm for 20-30 mins. Buffy layer will be centrifuged again at 1100 rpm for another 20-30 mins. The pellet thus formed will be suspended in 5ml of culture medium. The nucleated stem cells thus isolated, will be incubated at 37deg.C under 5%CO2 in culture flasks for about 4-6weeks. Those cells adherent to flask removed with 0.05% trypsin-EDTA sol and characterised . Those positive for CD90 and CD105 and negative for CD45 and CD34 will be the mesenchymal stem cells. These will then be expanded to 10×106 for use.

Also known as: MSC

Mesenchymal stem cell, PRP

PRP BIOLOGICAL

Twelve patients will be placed in supine position with knee in full extension and under full aseptic precautions 8-10 ml of platelet rich plasma would be injected by lateral approach with an 18-20 G needle.

Also known as: Platelet gel

Mesenchymal stem cell, PRP; platelet rich plasma

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Grade 1 or Grade 2 Osteoarthritis knee as per Ahlbacks radiographic staging
• Patients willing to give consent

You may not qualify if:

• Osteoarthritis secondary to joint inflammatory diseases (eg- rheumatoid arthritis, ankylosing spondylitis etc)
• Patients with other diseases, affecting the knee joint like crystal arthropathy, symptomatic chondrocalcinosis, acute synovitis, excessive joint effusion(\>100ml), cystic disease around the knee joint(eg-popliteal cyst)
• Advanced stage of osteoarthritis
• Bone marrow suppression
• Co morbidities like pregnancy, cancer, immunosuppression,
• Osteoarthritis secondary to trauma

Sponsors & Collaborators

• Aditya K Aggarwal: lead
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator

Study Sites (1)

Department of Orthopaedics Postgraduate Institute of Medical Education & Research

Chandigarh, Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Aditya K Aggarwal, MS,DNB,DO

  Post graduate institute of Medical Education & Research, Chandigarh, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Additional Professor Orthopaedic Surgery

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 15, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 18, 2013

Record last verified: 2013-11

Locations

IN (1)