Fetal Stem Cells in Chronic Wounds & Ulcer Treatment

DOCTOR ANDRII KUKHARCHUK

13 Apr, 2015

CHRONIC WOUND AND ULCER The mainstay of therapy for

severe, limb-threatening ischemia is either surgical or endovascular revascularization aiming to improve blood flow to the affected extremity. If revascularization has failed or is not possible, major amputation is often necessary. This relates to about 30% of all cases of severe limb ischemia, corresponding to about 100.000 major leg amputations in the EU, and to 120.000 in the US.

Leg amputation in atherosclerotic

PAD causes an acute mortality rate of around 30% and a grim five-year prognosis with a survival rate of less than 30%.

CHRONIC WOUND AND ULCER Nonhealing chronic wounds are a

large and growing problem with an incidence of 5–7 million cases per year in the United States only.

Chronic wounds are a cause of significant morbidity and mortality and pose a large financial burden on the healthcare system.

Despite the most recent advances in wound management, up to 50% of chronic wounds still fail to heal.

Regenerative potential of fetal progenitor cells can help in treatment of no healing wounds by 3 target points: activation of angiogenesis, induction of immune tolerance, and repair and regeneration of the skin.

CHRONIC WOUND AND ULCER Patient R., 66 yrs, M., Diabetic

Ulcer. Ulcer not healing during 120 days Doppler Study before treatment:Minimal flow is seen in the posterior tibial artery in the upper leg and the superior margin of the wound.There is almost complete block of the posterior tibial artery at the junction of the upper and mid third of the leg.Flow is mildly reduced in anterior tibial artery and dorsalis paedis artery around the ankle and in the foot.

Screening Photo

Before commencement of treatment

CHRONIC WOUND AND ULCER Patient R., 66 yrs, M., Diabetic Ulcer. 1st Step of Fetal Stem Cells

Treatment:Intravenous infusion of fetal liver hematopoietic stem cells (AC133+) & subcutaneously injection of neural stem cells from same fetus.Aim: Hematopoietic stem cells introduce

immunologic tolerance for all kinds of allogenic stem cells from same fetus + improve endothelial regeneration in arteries and veins.

Neural fetal stem cells restore innervations in zone of diabetic neuropathy.

Patient R., 66 yrs, M., Diabetic Ulcer.2nd Step of Fetal Stem Cells Treatment:Local multiple injection of fetal angioblasts and fetal neuroblasts along obliterated arteries

Aim

Creation new vascular network by stimulation of angiogenesis and vasculogenesis.

Restore local innervations in ischemic legs' tissue.

Patient R., 66 yrs, M., Diabetic Ulcer.3rd Step of Fetal Stem Cells Treatment:Local multiple injection of fetal angioblasts and fetal neuroblasts around the ulcer and in the bottom of the wound.

Aim

Creation new local vascular network by stimulation of angiogenesis and vasculogenesis.

Restore local innervations in ischemic tissue of wound.

Patient R., 66 yrs, M., Diabetic Ulcer.4rd Step of Fetal Stem Cells Treatment:Application of fetal tissue extracts (skin, muscle and umbilical cord) in autoplasma gel.

Aim

Activation of wound epithelialization

Patient R., 66 yrs, M., Diabetic Ulcer.14 days after introduction of cells. Wound on 14th day covered

ointment with recombinant epidermal growth factor. No epithelialization

Patient R., 66 yrs, M., Diabetic Ulcer.17 days after introduction of cells. Wound covered with

colloid silver and fetal skin extract gel. No epithelialization.

Patient R., 66 yrs, M., Diabetic Ulcer.20 days after introduction of cells. Size of the wound reduced. Wound cleaned from dead tissue and covered

with colloid silver and fetal skin extract gel. No epithelialization

Patient R., 66 yrs, M., Diabetic Ulcer.24 days after introduction of cells. Wound cleaned from

dead tissue. Implantation of 4 flaps (black arrow) fetal skin (14-15 weeks of gestation). Free surface

uncovered area by fetal skin of the wound covered with colloid silver and placental extract

Patient R., 66 yrs, M., Diabetic Ulcer.30 days after introduction of cells. 5 days after implantation

of fetal skin. Flaps of fetal skin absorbed. Epithelialization of edges started from all sides of wound (black arrow) under the impact of growth factors secreted from fetal

skin

Patient R., 66 yrs, M., Diabetic Ulcer.31 days after introduction of cells. Repeated implantation of

fetal skin for strengthening and acceleration of wound epithelialization.

Patient R., 66 yrs, M., Diabetic Ulcer.

46 days after introduction of cells. Repeated implantation of fetal skin (black arrow) + ointment "EPC-Universal":► Amorphous Hydrogel Wound

Dressing with Colloidal silver► Neomycin-Bacitracin

Sulphacetamide ► Fetal Hematopoietic Stem Cells

Extract ► Fetal Neural Stem Cells Extract► Fetal Thymus Extract► Fetal Umbilical Cord Tissue

Extract► Fetal Spleen Extract► Fetal Muscle & Skin Extracts

Patient R., 66 yrs, M., Diabetic Ulcer.

48 days after introduction of cells. Wound epithelialization is weak. Offered to make patient autologous skin transplantation with implantation of fetal skin.

But patient refused the operation.

Autoskin graftFetal skin

implants

Patient R., 66 yrs, M., Diabetic Ulcer.

49 days after introduction of cells. Wound epithelialization is weak.Second local multiple injections of fetal angioblasts and fetal neuroblasts around the wound.Repeated implantation of fetal skin.

HbA1C:Before treatment – 6.9%Now – [? I HAVE NOT ANALYSES COPY!!!] Estimated Average Glucose:Before treatment – 151.9 mg/dlNow – [? I HAVE NOT ANALYSES COPY!!!] Doppler Study: Compared to previous scan, there is extensive neovascularisation is noted in the bed of the wound.

Treatment continue

Patient R., 66 yrs, M., Diabetic Ulcer.

Before Fetal Stem Cells Treatment

Now (in Process of Fetal Stem Cells

Treatment)

Patient K., Male, Diabetic Foot. Necrotized tissues are observed (black arrow), canal filled with pus (white arrow)

Wound not healing during 90 days

Doppler Study before treatment:

Generalised atherosclerotic disease involving arteries of right lower limb.Extensive wall calcification is seen in anterior tibial artery, posterior tibial artery and dorsalis paedis artery.

Screening Photo

Before commencement of treatment

Patient K., Male, Diabetic Foot.

Necrotized tissues are removed. Two pus canals are cleaned (white arrow)

Patient K., Male, Diabetic Foot.Schematic representation of local wound treatment: points for

cells introduction

Patient K., Male, Diabetic Foot.

Treatment:1st Step. Intravenous infusion of fetal liver hematopoietic stem cells (AC133+) & subcutaneously injection of neural stem cells from same fetus.2nd Step. Local multiple injection of fetal angioblasts and fetal neuroblasts along obliterated arteries.3rd Step. Local multiple injection of fetal angioblasts and fetal neuroblasts around the ulcer and in the bottom of the wound (foto).4rd Step. Application of fetal tissue extracts (skin, muscle and umbilical cord) in autoplasma gel.

Patient K., Male, Diabetic Foot.6 days after introduction of cells. Edges of wound constringes.

Epithelializiation of wound started in the wound edges (white arrow) Granulation is clean covered with fibrin in some places (black arrow).

Patient walks independently. Not febrile.

Patient K., Male, Diabetic Foot.10 days after introduction of cells. Clean wound canal closed (black arrow). New skin epithelium “creeps” on the granulation

(white arrow). Patient walks independently. Not febrile.

Patient K., Male, Diabetic Foot.14 days after introduction of cells. Wound clean and canal is probed (black arrow), no pus. Epithelialization continues. Wound closed with ointment with recombinant epidermal growth factors. Patient walks

independently. Not febrile.

Patient K., Male, Diabetic Foot.17 days after introduction of cells. Clean wound and canal probed; no pus. In the canal and on the wound – ointment with colloid silver and fetal skin extract. Epithelialization continues. Patient walks independently. Not febrile.

Patient K., Male, Diabetic Foot.20 days after introduction of cells. Purulence of canal, febrile,

severe pain. Clean wound, canal probed, pus removed.

Patient K., Male, Diabetic Foot.20 days after introduction of cells. In the canal and on wound –

ointment with colloid silver and fetal skin extract.

Patient K., Male, Diabetic Foot.20 days after introduction of cells. Continuous epithelialization of

wound edges. Intramuscular cephalosporin 5th generation prescribed.

Patient K., Male, Diabetic Foot.24 days after introduction of cells. Again pus in the canals.

Wound is cleaned, canals probed and washed, pus removed. In canals – antibiotic ointment. On the wound – colloid silver gel and placental extracts. Continuous epithelialization of wound edges.

Patient K., Male, Diabetic Foot.30 days after introduction of cells. Canals probed and washed.

No pus. Continuous epithelialization of wound edges.

Patient K., Male, Diabetic Foot.30 days after introduction of cells. In canals antibiotic ointment

were introduced. Wound covered with colloid silver gel and placental extracts. Comparison foto: 3 days vs 30 days

3 days 30 days

Patient K., Male, Diabetic Foot.31st day: implantation of fetal skin for strengthening and

accelerating epithelialization of wound under the impact of fetal growth factors.

Patient K., Male, Diabetic Foot.37st day: accelerating of wound epithelialization. Wound covered

with colloid silver gel and placental extracts.

Patient K., Male, Diabetic Foot.38th day: pus in wound canals. Canal open and clearing.

Patient K., Male, Diabetic Foot.From 38th to 44th days: Wound covered with ointment “EPC

Universal”.

Patient K., Male, Diabetic Foot.46th days: Wound covered with ointment “EPC Universal”. In

canal – ointment “Levomicol”

Patient K., Male, Diabetic Foot.

49th days: implantation of fetal skin for strengthening and

accelerating epithelialization of wound under the impact of fetal

growth factors.HbA1C:Before treatment – 9.2%Now – [? I HAVE NOT THIS ANALYSES!!!]

Doppler Study: Compared to previous scan, there is extensive neovascularisation is noted in the bed of the wound.

Treatment continue

Patient K., Male, Diabetic Foot.

Before Fetal Stem Cells Treatment

Now

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

Wound not healing during 120 days

Doppler Study before treatment:[??? - I HAVE NOT THIS DATA!!! IMAGINE ONLY!!!]

Screening Photo

Before commencement of cells' treatment

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

Treatment:1st Step. Intravenous infusion of fetal liver hematopoietic stem cells (AC133+) & subcutaneously injection of neural stem cells from same fetus.2nd Local multiple injection of fetal angioblasts and fetal neuroblasts around the ulcer and in the bottom of the wound (foto).3rd Step. Application of fetal tissue extracts (skin, muscle and umbilical cord) in autoplasma gel.

Local introduction of cells

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

14 days after introduction of cells. Infection, pus. Prescribed I/M Gentamycin, 80 mg 2 times per day.

Wound is covered with disinfecting cream “Hydroheal AM” with the colloid silver

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

17 days after introduction of cells. Infection, pus. Wound cleaned from pus.

Prescribed I/M Gentamycin, 80 mg 2 times per day.Wound is covered with disinfecting cream “Hydroheal AM” with

the colloid silver + fetal skin extract

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

20 days after introduction of cells. Infection, pus.

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)20 days after introduction of cells. Wound cleaned.

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)20 days after introduction of cells. Applied antibiotic ointment on

wound: Mupirocin Oiment IP. Intramuscular cephalosporin 5th generation.

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

24 days after introduction of cells. Purulence and edema on the 2nd toe. Wound cleaned. Applied antibiotic ointment on wound:

Mupirocin Oiment IP. Intramuscular cephalosporin 5th generation. After demarcation line appears planned for

amputation of 2nd toe.

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

30 days after cells introduction. Toe amputation. Wound cleaned from pus.

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

30 after cells introduction. Antibiotic ointment applied on wounds.On 31st day planned to apply antibiotic ointment + fetal extract of liver with high content of tissue fibrinolysis activator.In cases of TAO in the zone of debridement micro-thrombosis are formed which blocks blood supply to small portions of the wound surface. As a result these portions in the wound constantly necrotize and form purulence. Activation of local fibrinolysis in wounds under impact of fetal liver extract can restore blood supply to small vessels and prevent small necrosis in the wounds.

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

On 31st day was apply antibiotic ointment + fetal extract of liver with high content of tissue fibrinolysis activator.

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

38 days: pus. On the wound - antibiotic ointment Bactroban. Per os – Warfarin & Trental

Patient Ch., M., Thromboangiitis obliterans

(Berger's disease)

40 days: wound clearing. Granulation appear. On the wound - antibiotic ointment Bactroban.

Patient Ch., M., Thromboangiitis obliterans

(Berger's disease)

41 days: wound epithelialization starting. On the wound - ointment "EPC Universal".

Patient Ch., M., Thromboangiitis obliterans

(Berger's disease)

46 days: fetal skin implantation.

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

48 days: wound epithelialization continue.

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

48 days: wound epithelialization continue. On the wound – ointment "EPC Universal"

Patient Ch., M., Thromboangiitis obliterans

(Berger's disease)

49 days: fetal skin implantation.

Doppler Study:Compared to previous study, there is marginal improvement in the vascularity of the wound.

Treatment continue

Patient Ch., M., Thromboangiitis obliterans (Berger's disease)

Before Fetal Stem Cells Treatment

Now(after 3.5 months)

48 days after Fetal Stem Cells Treatment

THANK YOU