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Mesenchymal Stem Cells Enhanced With PRP Versus PRP In OA Knee (MSCPRPOAK)

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ClinicalTrials.gov Identifier: NCT01985633
Recruitment Status : Unknown
Verified November 2013 by Aditya K Aggarwal, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
First Posted : November 15, 2013
Last Update Posted : November 18, 2013
Sponsor:
Collaborator:
Postgraduate Institute of Medical Education and Research
Information provided by (Responsible Party):
Aditya K Aggarwal, Postgraduate Institute of Medical Education and Research

Tracking Information
First Submitted Date  ICMJE November 5, 2013
First Posted Date  ICMJE November 15, 2013
Last Update Posted Date November 18, 2013
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2013)
Pain relief [ Time Frame: Participants will be followed upto an average of 6months. ]
Pain will be measured using Visual analogue scale (VAS)which consists of markings from 1 to 10.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01985633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2013)
Functional Outcome [ Time Frame: Participants will be followed upto an average of 6months. ]
Functional Outcome will be assessed by Western Ontario and McMaster Universities score(WOMAC)and Knee Injury and Osteoarthritis Outcome Scores(KOOS) at 6weeks, and 6months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 10, 2013)
Quantitative articular cartilage volume analysis [ Time Frame: Participants will be followed upto an average of 6months. ]
by MRI of the knee joint. will be obtained on a GE 3.0 T magnet in the sagittal coronal planes using matching excitation times (NEX), repetition times (TR), and echo times (TE).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cells Enhanced With PRP Versus PRP In OA Knee
Official Title  ICMJE Autologous Bone Marrow Derived Mesenchymal Stem Cells Enhanced With Platelet Rich Plasma Versus Platelet Rich Plasma In Osteoarthritis Knee:A Comparative Study
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.
Detailed Description

Mesenchymal stem cells (MSCs) are nonhematopoietic progenitor cells isolated from adult tissues. These are characterized in vitro by their extensive proliferative ability in an uncommitted state while retaining the potential to differentiate along various lineages of mesenchymal origin, including chondrocyte, osteoblast, and adipocyte lineages, in response to appropriate stimuli.MSCs can be induced to undergo chondrogenic differentiation in vitro and in vivo. Centeno et al.in 2008 reported about the beneficial effects of autologous mesenchymal stem cells in osteoarthritis of knee. The regenerative effects of MSCs in osteoarthritis can be due to their ability to differentiate themselves into chondrocytes and structurally repair the articular cartilage. Recently, MSCs have been shown to possess many potent paracrine effects through secretion of various soluble factors which can influence the local tissue environment and exert protective effects with an end result of effectively stimulating regeneration in situ. Recently Amgad etal.in their study reported even more effective results with use of platelet rich plasma along with mesenchymal stem cells. Platelets play an instrumental role in the normal healing response via the localsecretion of growth factors and recruitment of reparative cells. Its use in orthopaedic began early in this decade as PRP was used with bone grafts to augment spinal fusion and fracture healing.

Wakitani et al. in 1994 described repair of defects in articular cartilage in rabbits.Murphy et al.studied the effects of autologous mesenchymal stem cells in caprine knee joints.Quarto et al.reported the ability of mesenchymal stem cells to repair a large musculoskeletal defect with successful healing of a large bone defect in three patients. Centeno et al. reported one case in which they showed that isolated and expanded autologous mesenchymal stem cells when percutaneously injected into a knee with symptomatic and radiographic osteoarthritis, resulted in significant cartilage growth, decreased pain and increased joint mobility. Mishra et al. reported that PRP could enhance the chondrogenic differentiation of MSCs, and that TGFbeta and fibroblast growth factor (FGF) signaling, which are factors present within PRP, were important for chondrogenic differentiation of MSCs.Hence present study is designed to study the efficacy of use of PRP enhanced mesenchymal stem cells in osteoarthritis knee.

AIMS AND OBJECTIVES

  1. To evaluate the safety and efficacy of Platelet rich plasma enhanced autologous mesenchymal stem cells versus platelet rich plasma in knee osteoarthritis.
  2. To correlate the clinical improvement with the radiological findings.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Biological: Mesenchymal stem cell suspension
    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.
    Other Name: MSC
  • Biological: PRP
    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.
    Other Name: Platelet gel
Study Arms  ICMJE
  • Experimental: Mesenchymal stem cell, PRP
    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
    Interventions:
    • Biological: Mesenchymal stem cell suspension
    • Biological: PRP
  • Active Comparator: platelet rich plasma
    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.
    Intervention: Biological: PRP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 10, 2013)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Osteoarthritis secondary to joint inflammatory diseases (eg- rheumatoid arthritis, ankylosing spondylitis etc)
  2. 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)
  3. Advanced stage of osteoarthritis
  4. Bone marrow suppression
  5. Co morbidities like pregnancy, cancer, immunosuppression,
  6. Osteoarthritis secondary to trauma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 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 India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01985633
Other Study ID Numbers  ICMJE Adi_MSC_PRP_OA_2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aditya K Aggarwal, Postgraduate Institute of Medical Education and Research
Study Sponsor  ICMJE Aditya K Aggarwal
Collaborators  ICMJE Postgraduate Institute of Medical Education and Research
Investigators  ICMJE
Principal Investigator: Aditya K Aggarwal, MS,DNB,DO Post graduate institute of Medical Education & Research, Chandigarh, India
PRS Account Postgraduate Institute of Medical Education and Research
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP