QUALITY POLICY -

At TRICell, we are committed to provide clinical research services to support our clients clinical development pipelines, by using standard Guide lines for meeting the clients expectations of quality and performance of the project, with the timely submission of the report. We are also committed to the continuous improvement of the system and regular personnel training with ethics to establish the benefits of treatments that enhance peoples lives"

MISSION

Our Mission is to provide Clinical research services, maintaining the regulatory standards with the understanding of government procedures in India to establish the benefits of treatments that enhance people’s lives.

VISION

To establish ourselves as a pioneer in the Clinical research services in the next generation treatment of our clients research which enhance people’s life.

The Center is embarking on a Clinical trial in Peripheral Vascular Disorder (Critical Limb Ischemia) using autologous Bone marrow stem cells. The study will be carried out in collaboration with the Vascular Surgery Department, Sri Ramachandra University and Harvest Technologies, USA. We are planning to conduct trials in Diabetes, CABG, Neurological disorders and dentistry. using autologous bone marrow aspirate concentrate (BMAC) and platelet rich plasma (PRP)

Trial in Critical limb ischemia

INTERIM CLINICAL STUDY REPORT
(Conducted in Sri Ramachandra medical college)

OBJECTIVES:

The primary objective of this clinical study was to evaluate the safety and activity of a concentrate of nucleated cells from bone marrow aspirate concentrate (BMAC) produced with the Harvest Bone Marrow Aspirate Concentrate System for treating lower limbs diagnosed with critical ischemia due to PAOD.

METHODOLOGY:

This was a prospective, randomized open label, single center clinical investigation of a medical device which produces BMAC. The study evaluated the effect of treating criticallimb ischemia with multiple injections (intramuscular, or intramuscular and intra-arterial) of BMAC.

DURATION OF TREATMENT

All randomized subjects were evaluated on week 1, week 4, week 8 and week 12 post treatment, to assess the effect of treatment and to develop initial safety database.

Clinical end points

Subject’s  perception of pain (analog pain scale).
Amputation-free survival
 Pain-free walking distance (claudication)

CONCLUSIONS

Based on the results of the interim analysis, it can be concluded that the BMAC obtained from Harvest Bone Marrow Aspirate Concentrate System for the treatment of non reconstructable critical limb ischemia due to peripheral arterial occlusive disease is safe and has shown to improve the quality of life. It has also given a proof of its efficacy in reducing perception of pain and improvement in various objective measurements like TcPO2, ABI and pain free walking distance. Also, this study has shown that, both the methods of deliveries of BMAC are equally effective and safe.