Treatment procedure

From FETAL PRECURSOR CELL TRANSPLANTATION (FPCT)
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All fetal precuror cell transplants prepared for the named (and ‘coded’) patient are implanted at the same time under sterile conditions in the minor operating room. Standard precautions must be used for the care of patients, i.e. appropriate handwashing, use of barrier precautions, care in the use and disposal of needles and other sharp instruments, proper procedures for handling and disinfection/sterilization of medical instruments and disposal of potentially infectious waste in order to minimize transmission of nosocomial pathogens or possible xenogeneic infections. No additional infection control or isolation precautions have to be employed in view of lack of such transmission of xenogeneic infections in many years of our clinical experience and since no immunosuppression is used.


Procedure is preferrably carried out in the morning after patient had a small breakfast.


Space requirements: minor operating room or aseptic procedure room with adjacent aseptic preparation room where fetal precursor cell transplants are loaded from the transportation vials into the implantation syringes.


Personnel requirement: one physician / surgeon to carry out cell transplantation, one senior laboratory technician to load fetal precursor cell transplants from transportation vials to implantation syringes, nursing staff.


Supplies: 18 g 3” epidural anesthesia (or liver biopsy) needles with blunt end and opening on the side for subaponeurotic and intrathecal (lumbar puncture) implantation, 18 GA 2” needles for deep gluteal epifascial implantation, 18 GA 2” needles for drawing of cell transplants from the transportation vials into syringes, 5 cm3 Luer-Lock syringes for implantation, 70% alcohol, Betadin tincture, 1% Xylocaine (without Epinephrine), sterile physiological solution, tuberculine syringes with 30 GA needles, 4x4 gauze, small window drapes, small regular drapes, Band-Aids, 3 metal trays, surgical greens + hats + masks + boots + sterile gloves.


Procedure:

Put on greens, hat and shoe covers, and surgical mask.

In preparation room load fetal cell transplants into Luer-Lock syringes.

Take out all transportation vials from the package, check the label on each vial, shake each one thoroughly, and then line them up on the ‘Implantation Scheme’ that you received with fetal precursor cell transplants from the manufacturer.

Prepare as many 5 cm3 Luer-Lock syringes, 18 GA 2” needles, and 18 GA implantation needles as there are transportation vials. Note that implantation needles for subaponeurotic and intrathecal (lumbar puncture) implantation are the same, while implantation needles for deep epifascial gluteal implantation are ordinary 18 GA 2” ones.

Cover a surgical tray on wheels with a sterile drape. Place stickers with the visible name of fetal precursor cell transplants on the drape in the same way as displayed on the ‘Implantation Scheme’.

Put on sterile gloves.

Ask your assistant to take the first vial with fetal precursor cell transplant, shake it thoroughly, open the screwed on top. Take a Luer-Lock syringe, attach 18 GA drawing needle, and draw the contents of the vial into syringe. – Note that transportation vial have a peculiar bottom with a sharp narrow end where clusters of cell transplants often get stuck. If that has happened, have your assistant put the top back on and repeat vigorous shaking. If even that does not solve the problem, then dislodge the clustered ‘glued on’ cells at the bottom with the tip of drawing needle.

Express the drawn in air and place the filled up syringe on its designated place (by a sticker) on the surgical drape.

Repeat the same procedure with all vials containing fetal precursor cell transplants manufactured for the patient identified by a code on a label of each transportation vial.

Then wheel the surgical tray into the treatment room.


Subaponeurotic implantation:

With a patient in a supine position prep the upper abdomen, umbo, and area just below belly button, with Betadin soap and solution three times, like for an abdominal surgery.

Select a spot approximately ½” superiorly and ½” laterally from umbo, and carry out intradermal anesthesia of those tiny skin areas with 1% xylocaine in tuberculin or 1 cc syringe, and do so bilaterally.

Attach 18 GA epidural anesthesia needle to a Luer-Lock syringe containing fetal cell transplant that is marked on the ‘Implantation Scheme’to go RIGHT UP. – Note that epidural anesthesia needle has a blunt end, and its opening is on the side. – Line up the needle so that the flat side of the end with the opening is parallel with the wings on the Luer-Lock syringe; that will help you during the implantation to be always oriented about the position of the opening of the needle.

Take the syringe with attached needle in your hand in such a way that the opening of the needle is parallel with and facing the abdominal skin of the patient. Then turn your hand in such a way that the syringe with attached needle is at the right angle to the abdominal skin at the point marked with the ‘wheel’ from your intradermal anesthesia right to and up from the belly button. Then pierce the skin with enough force to push the tip of needle into subcutaneous tissue. - Beware that it is hard to pierce the skin with such blunt needle: do not be afraid to use adequate force to penetrate skin. Holding the syringe with needle at right angle to the skin makes the skin penetration easier.

After the skin penetration change the direction of the syringe with needle into oblique and direct it to the right side of the patient’s body and upward toward the axilla. Advance the needle tip, and then probe with the needle tip for the surface of the aponeurosis of rectus abdominis muscle. In some patients the aponeurosis may be weak, and hard to palpate: ask the patient to push down like for a bowel movement, whereupon aponeurosis of rectus abdominis muscle becomes hard and palpable with the tip of the needle.

Making sure that the needle opening is parallel to and facing the surface of the aponeurosis of rectus abdominis muscle, palpate its surface, and if the needle tip is touching it, pierce the aponeurosis by a jolt like when penetrating the wall of the vein during i.v. injection.

After the penetration of aponeurosis do aspirate, and then inject the contents of the syringe, not too fast, not too slow.

After you injected the entire contents of the syringe, separate the Luer-Lock syringe from the needle, and attach to it the syringe with 1% xylocaine. Inject 0.2. cc of xylocaine to implant the cells that remained in the implantation needle.

Withdraw the needle from under the aponeurosis back into the subcutaneous space – but do not pull it out of subcutaneous space(!). Re-attach the Luer-Lock syringe that contains the next fetal precursor cell transplant marked on the ‘Implantatation Scheme’ to go RIGHT DOWN.

Change the direction of the needle/syringe into oblique going to the right side of the patient and downward toward the groin. Advance the needle tip and probe with the needle tip for the surface of the aponeurosis of rectus abdominis muscle . Making sure that the needle opening is parallel to and facing the surface of the aponeurosis of rectus abdominis muscle, palpate its surface, and if the needle tip is touching it, pierce the aponeurosis by a jolt like when penetrating the wall of the vein during i.v. injection. After the penetration of aponeurosis, aspirate and then inject the contents of the syringe, not too fast, not too slow.

Then withdraw the syringe with needle.

Repeat the above steps on the left side of the patient’s body always following the ‘Implantation Scheme’. - Apply band-aids to the skin puncture points.


Gluteal implantation:

After subaponeurotic implantations, ask the patient to turn into a prone position and carry out a surgical scrub of upper gluteal regions bilaterally with Betadine soap and solution three times.

Technique of deep epifascial implantations is the same as that of deep subcutaneous injections.

Implant all pre-prepared stem cell transplants in accordance with the ‘Implantation Scheme’.

Cover the puncture marks with Band-Aids.


Intrathecal implantation:

Depending upon the therapeutic indication it can be done either utilizing a lumbar puncture or a ventricular tap technique.

a/ Technique via lumbar puncture :

Using 18 GA lumbar puncture needle carry out a standard lumbar puncture. Allow 5 cc of cerebrospinal fluid to drain out, and then implant the contents of the syringe pre-filled with the fetal precursor cell transplant as per ‘Implantation Scheme’. If two different fetal precursor cell transplants are to be implanted, wait 3 – 5 minutes after the first implantation, drain again 5 cc of cerebrospinal fluid, and then implant the contents of the second syringe pre-filled with the 2nd fetal cell transplant as per ‘Implantation Scheme’. Apply Band-Aid to the skin puncture site.

If the third fetal cell transplant is to be implanted, repeat the step no. 2.

Place the patient in a supine position without any pillow for 24 hours as is routinely done after the lumbar puncture.


b/ Technique via ventricular tap :

In the operating room, with the patient awake, local anesthesia is carried out for incision of skin and soft tissues overlying the area of the Burr hole to be made. After skin incision, which is extended deeply to the level of skull, Burr hole is made. Dura mater is exposed, and 18 GA ventricular tap needle inserted into Cornu Ammonis of the lateral ventricle of the brain. After draining 5 cc of cerebrospinal fluid the contents of the syringe with fetal precursor cell transplant as per ‘Implantation Scheme’ are implanted. If another fetal precursor cell transplant is to be implanted, wait 10 minutes, again drain 5 cc of cerebrospinal fluid and then implant the contents of another syringe with cell transplant as per ‘Implantation scheme’.

Observe dura mater for possible signs of intra-cerebral hematoma for 10 minutes, secure hemostasis of dura mater, bone margins, suture the soft tissues and skin.



Fetal cell transplantation IMPLANTATION SCHEME for:


Name of Patient: ____________________

Date of Transplantation: _____________________

ANTERIOR – REGIO SUPRA-UMBILICALIS MEDIALIS

dextra: sinistra:

RIGHT UP:

LEFT UP:

RIGHT DOWN:

LEFT DOWN:


O O


UMBO


_________________________________________________________________


POSTERIOR - REGIO GLUTEALIS

sinistra: dextra:



O O O O O O


___________________________________________________________________________

INTRATHECAL:

1/

2/

3/

______________________________________________________________________________


Treatment has to be repeated every 9 - 36 months, the exact timing is determined usually on clinical grounds by the respective specialist observing a recurrence of the progression of the complication. There does appear however to be some degree of cumulative effect as the next stem cell transplantation often gives a better and longer lasting result than the first one.