Bioheart announces first ever combination stem cell trial in India
For treating patients with congestive heart failure
Bioheart, a Sunrise, Florida, US-based developer of cell therapies for cardiovascular diseases, has begun two clinical trials in India, including the first ever combination stem cell trial.
The first cardiac patient has successfully been enrolled and treated in India using AdipoCell (adipose derived stem cells). The second trial will involve the combination of AdipoCell and MyoCell (muscle derived stem cells) for congestive heart failure patients. AdipoCell may help to promote angiogenesis (new blood vessel formation) in ischemic tissue, while MyoCell may help to promote myogenesis (new muscle formation).
Study manager Himanshu Bansal said: 'With India's population and growing middle class the opportunities with Bioheart are limitless and we have many patients in India who can benefit from regenerative medicine and the Bioheart products. Conducting the first ever combination stem cell trial in the world will provide insights into future treatments.'
Bioheart and biotechnology company Revita Lifesciences are funding the trials.
The first patient has been treated at the Yatharth Hospital at Noida. This study will complement data completed in the ANGEL trial on patients with congestive heart failure (CHF). All patients will receive delivery into the damaged areas of the heart using the MyoCath catheter. Data endpoints will include safety, exercise capacity, quality of life, and ejection fraction at three and six months.
'Every week Bioheart is receiving interest from around the globe and conducting trials in India is another example of our team answering that call,' said Kristin Comella, Bioheart's Chief Science Officer. 'Bioheart therapies are now being utilised in over a dozen countries around the globe.'
MyoCell is a clinical muscle-derived cell therapy that populates regions of scar tissue within a patient's heart with new living cells to improve cardiac function in chronic heart failure patients.
