MS Ramaiah Medical College Hospitals

Bangalore, India

MS Ramaiah Medical College Hospitals

Bangalore, India
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Dubey A.P.,Maulana Azad Medical College & Hospital | Agarkhedkar S.,Dr DY Patil Medical College & Hospital | Chhatwal J.,Christian Medical College & Hospital | Narayan A.,MS Ramaiah Medical College & Hospitals | And 4 more authors.
Human Vaccines and Immunotherapeutics | Year: 2016

Dengue is a mosquito-borne viral disease that is endemic in India. We evaluated the immunogenicity and safety of recombinant, live-attenuated, tetravalent dengue vaccine (CYD-TDV) in Indian adults. In this observer-blind, randomized, placebo-controlled, Phase II study, adults aged 18–45 years were randomized 2:1 to receive CYD-TDV or placebo at 0, 6 and 12 months in sub-cutaneous administration. Immunogenicity was assessed using a 50% plaque reduction neutralization test (PRNT50) at baseline and 28 days after each study injection. 189 participants were enrolled (CYD-TDV [n = 128]; placebo, [n = 61]). At baseline, seropositivity rates for dengue serotypes 1, 2, 3 and 4 ranged from 77.0% to 86.9%. Seropositivity rates for each serotype increased after each CYD-TDV injection with a more pronounced increase after the first injection. In the CYD-TDV group, geometric mean titres (GMTs) were 2.38 to 6.11-fold higher after the third injection compared with baseline but remained similar to baseline in the placebo group. In the CYD-TDV group, the GMTs were 1.66 to 4.95-fold higher and 9.23 to 24.6-fold higher after the third injection compared with baseline in those who were dengue seropositive and dengue seronegative, respectively. Pain was the most commonly reported solicited injection site reaction after the first injection in both the CYD-TDV (6.3%) and placebo groups (4.9%), but occurred less frequently after subsequent injections. No serious adverse events were vaccine-related, no immediate unsolicited adverse events, and no virologically-confirmed cases of dengue, were reported during the study. The immunogenicity and safety of CYD-TDV was satisfactory in both dengue seropositive and seronegative Indian adults. © 2016, © Anand Prakash Dubey, Sharad Agarkhedkar, Jugesh Chhatwal, Arun Narayan, Satyabrata Ganguly, T Anh Wartel, Alain Bouckenooghe, and Josemund Menezes.


PubMed | c Christian Medical College & Hospital, MS Ramaiah Medical College & Hospitals, Sanofi S.A., b Dr DY Patil Medical College & Hospital and 2 more.
Type: Clinical Trial, Phase II | Journal: Human vaccines & immunotherapeutics | Year: 2016

Dengue is a mosquito-borne viral disease that is endemic in India. We evaluated the immunogenicity and safety of recombinant, live-attenuated, tetravalent dengue vaccine (CYD-TDV) in Indian adults. In this observer-blind, randomized, placebo-controlled, Phase II study, adults aged 18-45 years were randomized 2:1 to receive CYD-TDV or placebo at 0, 6 and 12 months in sub-cutaneous administration. Immunogenicity was assessed using a 50% plaque reduction neutralization test (PRNT50) at baseline and 28 days after each study injection. 189 participants were enrolled (CYD-TDV [n = 128]; placebo, [n = 61]). At baseline, seropositivity rates for dengue serotypes 1, 2, 3 and 4 ranged from 77.0% to 86.9%. Seropositivity rates for each serotype increased after each CYD-TDV injection with a more pronounced increase after the first injection. In the CYD-TDV group, geometric mean titres (GMTs) were 2.38 to 6.11-fold higher after the third injection compared with baseline but remained similar to baseline in the placebo group. In the CYD-TDV group, the GMTs were 1.66 to 4.95-fold higher and 9.23 to 24.6-fold higher after the third injection compared with baseline in those who were dengue seropositive and dengue seronegative, respectively. Pain was the most commonly reported solicited injection site reaction after the first injection in both the CYD-TDV (6.3%) and placebo groups (4.9%), but occurred less frequently after subsequent injections. No serious adverse events were vaccine-related, no immediate unsolicited adverse events, and no virologically-confirmed cases of dengue, were reported during the study. The immunogenicity and safety of CYD-TDV was satisfactory in both dengue seropositive and seronegative Indian adults.


PubMed | Stempeutics Research Pvt Ltd, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Kasturba Medical College and Hospital, Ms Ramaiah Medical College & Hospitals and Jehangir Hospital
Type: Journal Article | Journal: Arthritis research & therapy | Year: 2016

Osteoarthritis (OA) is a common and debilitating chronic degenerative disease of the joints. Currently, cell-based therapy is being explored to address the repair of damaged articular cartilage in the knee joint.The in vitro differentiation potential of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (Stempeucel) was determined by differentiating the cells toward the chondrogenic lineage and quantifying sulfated glycosaminoglycan (sGAG). The mono-iodoacetate (MIA)-induced preclinical model of OA has been used to demonstrate pain reduction and cartilage formation. In the clinical study, 60 OA patients were randomized to receive different doses of cells (25, 50, 75, or 150 million cells) or placebo. Stempeucel was administered by intra-articular (IA) injection into the knee joint, followed by 2ml hyaluronic acid (20mg). Subjective evaluations-visual analog scale (VAS) for pain, intermittent and constant osteoarthritis pain (ICOAP), and Western Ontario and McMaster Universities Osteoarthritis (WOMAC-OA) index-were performed at baseline and at 1, 3, 6, and 12months of follow-up. Magnetic resonance imaging of the knee was performed at baseline, and at 6 and 12months follow-up for cartilage evaluation.Stempeucel differentiated into the chondrogenic lineage in vitro with downregulation of Sox9 and upregulation of Col2A genes. Furthermore, Stempeucel differentiated into chondrocytes and synthesized a significant amount of sGAG (301.8g/g GAG/DNA). In the preclinical model of OA, Stempeucel reduced pain significantly and also repaired damaged articular cartilage in rats. In the clinical study, IA administration of Stempeucel was safe, and a trend towards improvement was seen in the 25-million-cell dose group in all subjective parameters (VAS, ICOAP, andWOMAC-OA scores), although this was not statistically significant when compared to placebo. Adverse events were predominant in the higher dose groups (50, 75, and 150 million cells). Knee pain and swelling were the most common adverse events. The whole-organ magnetic resonance imaging score of the knee did not reveal any difference from baseline and the placebo group.Intra-articular administration of Stempeucel is safe. A twenty-five-million-cell dose may be the most effective among the doses tested for pain reduction. Clinical studies with a larger patient population are required to demonstrate a robust therapeutic efficacy of Stempeucel in OA.Clinicaltrials.gov NCT01453738 . Registered 13 October 2011.


Aishwarya K.C.,Kvg Medical College And Hospital | Srinath M.G.,MS Ramaiah Medical College Hospitals | Desai S.C.,MS Ramaiah Medical College Hospitals | Ashok Kumar A.,MS Ramaiah Medical College Hospitals | And 2 more authors.
Journal of Clinical and Diagnostic Research | Year: 2014

Objective: To know the value of preoperative Dopplerultrasonography vascular mapping of upper limb for hemodialysis access placement. Materials and Methods: Prospective ultrasonographic assess-ment of upper extremity vessels was performed in 60 patients prior to hemodialysis access placement and potential access sites were selected (based on the standard criteria). The findings were correlated with the operative findings. Discrepancies found between ultrasonographic and operative findings were analysed. Results: All the 60 patients who underwent vascular mapping had vascular access placed. 80% of them had native arteriovenous fistulae (AVF) placed. In 95% of patients, at the selected sites, the vascular parameters as determined by ultrasonography matched with the operative findings. In 5%of patients there were discrepancies between the ultrasonography findings and operative findings. There was no negative surgical exploration. There was strong correlation between the diameters measured by ultrasonography and surgery. Conclusion: Preoperative ultrasonography vascular mapping prior to hemodialysis access placement has facilitated definite selection of potential sites in difficult patient population in whom evaluation by physical examination was inconclusive. It also helped in maximizing the native AVFs and decreasing the negative surgical exploration rates. © 2014 Journal of Clinical and Diagnostic Research. All Rights Reserved.


PubMed | Kvg Medical College & Hospital and MS Ramaiah Medical College Hospitals
Type: Journal Article | Journal: Journal of clinical and diagnostic research : JCDR | Year: 2015

To know the value of preoperative Dopplerultrasonography vascular mapping of upper limb for hemodialysis access placement.Prospective ultrasonographic assess- ment of upper extremity vessels was performed in 60 patients prior to hemodialysis access placement and potential access sites were selected (based on the standard criteria). The findings were correlated with the operative findings. Discrepancies found between ultrasonographic and operative findings were analysed.All the 60 patients who underwent vascular mapping had vascular access placed. 80% of them had native arteriovenous fistulae (AVF) placed. In 95% of patients, at the selected sites, the vascular parameters as determined by ultrasonography matched with the operative findings. In 5% of patients there were discrepancies between the ultrasonography findings and operative findings. There was no negative surgical exploration. There was strong correlation between the diameters measured by ultrasonography and surgery.Preoperative ultrasonography vascular mapping prior to hemodialysis access placement has facilitated definite selection of potential sites in difficult patient population in whom evaluation by physical examination was inconclusive. It also helped in maximizing the native AVFs and decreasing the negative surgical exploration rates.

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