Clinical results

The clinical efficacy of Myskin™ to promote wound healing in patients with chronic neuropathic foot ulcers was evaluated in a pilot clinical study.

Six diabetic patients with neuropathic ulcers resistant to conventional therapy were treated with weekly applications of autologous keratinocytes delivered on myskin in addition to conventional therapy until wound healing was achieved. The results are summarised in the table below.

Patient	Age (yr)	Diabetes		Duration of Ulcer(s)	Response to myskin
Patient	Age (yr)	Type	Duration	Duration of Ulcer(s)	Response to myskin
1	43	1	22 years	1. 4 years 2. 3 months 3. 4 weeks 4. 4 weeks	Decrease in size 10 applications before healing 6 applications before healing Decrease in size after 8 applications (treatment ongoing)
2	56	1	30 years	2 years	8 applications before healing
3	46	1	29 years	16 months	6 applications before healing
4	64	2	12 years	10 months	No response after 24 applications
5	65	2	15 years	2 years	Treatment discontinued after 3 applications due to MRSA infection
6	63	2	19 years	3 months	10 applications before healing

Complete healing was achieved in six out of nine ulcers in six patients, a reduction in ulcer size was achieved in one ulcer and no response was seen in one ulcer. Treatment was discontinued in one patient due to infection. Complete wound healing required between 6 and 17 applications over a period of 6-20 weeks. There were no recurrences in the healed ulcers after a follow-up of 6 months. M. Moustafa, et al. A new autologous keratinocyte dressing treatment for non-healing diabetic neuropathic foot ulcers. Diabet. Med. 21 (7): 786-789, 2004.

In separate case-by-case studies, patients with a range of non healing wounds were treated with myskin and the results are summarised in the table below.

Patient	Age	Clinical Condition	Response to myskin
1	28	Acute burn injury (28% BSA)	Accelerated re-epithelialisation following the application of MySkin Improved healing following the application of MySkin
2	9	Acute burn injury (40% BSA)	Accelerated re-epithelialisation following the application ofMySkin Improved healing following the application of MySkin
3	81	Extensive chronic wounds (8 weeks duration) on both legs following partial skin graft failure after 28% flame burns	Left leg: 98% healed after 12 applications Right Leg: 78% healed after 12 application
4	64	Burns injuries to left foot and ankle led to contractures and ankle deformity which resulted in 3 year non healing chronic ulcers. Ulcers recurred despite 3 separate episodes of skin grafting.	Anterior ulcer completely healed after 22 applications while posterior ulcer is healed after 42 applications
5	83	Chronic ulcers to right leg of more than 60 years duration which developed while the patient was a prisoner of war in World War II. Six episodes of skin grafting failed to achieve permanent wound closure.	Partial healing of both ulcers with general improvement of the wound and the patient’s quality of life
6	44	12 year history of non-healing scalp wounds following initial excision and SSG of full thickness flame burns (15% BSA)	2 Ulcers healed after 2 applications; 2 partially healed after 18 application
7	82	Non healing pretibial wound (6 week duration) secondary to wound dehiscence following debridement and direct closure of a pretibial laceration. The patient was not considered suitable for further surgical intervention because of a postoperative cardiac event.	Complete wound closure following 7 applications; wound remains healed with 6 month follow up.

For 2 burns patients, myskin facilitated healing of grafted burns wounds. For 5 patients with intractable chronic wounds (with 9 ulcers in total) repeated applications of myskin resulted in complete healing in 5/9 ulcers with a major reduction in ulcer size for all other (4/9 ) ulcers. This reduction in ulcer size improved the wound conditions for 2 of these patients such that they were then considered suitable for conventional grafting and orthopaedic surgery respectively. N Zhu et al. Treatment of Burns and Chronic Wounds Using a New Cell Transfer Dressing for Delivery of Autologous Keratinocytes Eur. J. Plast. Surg. 2005, 28, 319–330.