Stempeutics Research, a group company of Manipal Education & Medical Group,
has announced that Drug Controller General of India (DCGI) has granted clearance
of the company’s investigational medicinal product 'stempeucel' for conducting
phase II clinical trials in patients with Critical Limb Ischemia (CLI) due to
Buerger’s disease. This trial is non-randomised, open labelled, multi-centric
and dose finding study. Earlier Stempeutics has completed the phase I part of
the trial approved by DCGI. Based on the outcome of phase I trial – DCGI
has granted clearance of Phase II trial. 'Stempeucel' product is developed from
allogeneic mesenchymal stem cells derived from donated bone marrow using Stempeutics
proprietary technology.
Commenting on the phase II trial approval, BN Manohar, CEO, Stempeutics Research
said “Through Phase I trial we could establish the safety of 'stempeucel'
product for CLI patients and through this Phase II trial we would like to establish
the efficacy and the optimum dose. The Phase II trial recruitment is likely
to be completed by middle of 2012. Upon successful outcome of phase II trial,
the company will be filing for Phase III approval in early 2013. He further
added that based on preclinical study 'stempeucel' have been found to be non-toxic,
non-teratogenic and non-tumourigenic in nature. Also the product has shown good
efficacy in CLI animal model.”
Incidence of CLI is estimated to be approximately 50 to 100 patients per lakh
per year and 10-40 per cent of them are at the risk of primary amputation. The
prevalence of the Buerger’s disease among all patients with CLI varies
from as low as 0.5 to 5.6 per cent in Western Europe to as high as 45 to 63
per cent in India. Patients with CLI have a one and 10 year mortality of approximately
20 per cent and 75 per cent respectively. Buerger’s disease is a non-atherosclerotic
segmental inflammatory disease that most commonly affects young male heavy smokers.
This disease is predominantly seen among people of low socio-economic class
who smoke bidis (homemade cigarettes with raw tobacco).
The symptoms of Buerger’s disease include pain in the legs, which initially
will be on prolonged walking, and gradually even during rest. There can be ulcers
in the limb, which may progress to gangrene, leading to amputation of the foot
/ entire limb. Currently there is no effective treatment available for Buerger’s
disease. Complete discontinuation of cigarette smoking or other use of tobacco
in any form may help to a certain extent. Surgical revascularisation (by-pass
surgery) is usually not possible for patients with Buerger’s disease, because
of the diffuse segmental involvement and distal nature of the disease. In certain
cases, Lumbar sympathectomy may be helpful in healing of superficial ischemic
ulcerations. It is expected that “stempeucel” may possibly address
the issues related to this disease. When injected by the intramuscular route
in the affected limb, it can lead to formation of new blood vessels or neo-angiogenesis.
This in turn may relieve the rest pain, heal the ulcers and prevent amputation.
In this Phase II trial, a total of 126 patients will be recruited at study centres
across India. Clinical follow up of each patient will be for two years from
the date of 'stempeucel' administration. The primary efficacy endpoints are
relief of the rest pain and secondly healing of ulcerations or reduction of
ulcer area in the target limb. The secondary efficacy endpoints are pain free
walking distance, major amputation free survival, ankle brachial pressure index
(ABPI) – measured by Doppler, increase in transcutaneous partial oxygen
pressure, quality of life by King's College VascuQOL questionnaire and finally,
angiogenesis – collateral blood vessels by magnetic resonance angiogram
(MRA). This CLI trial will be conducted in major cities such as Delhi, Chennai,
Bangalore and Kolkata.
