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Information on Peripheral Blood Stem Cells Donation

Filgrastim (Granulocyte Colony Stimulating Factor, G-CSF)

G-CSF is a hematopoietic growth factor that can be used to stimulate bone marrow to produce hematopoietic stem cells to be released into bloodstream, and then collected through a process called apheresis.

In many developed countries G-CSF is commonly given to cancer patients who underwent chemotherapy, or bone marrow transplantation, to increase the number of white blood cells. It is also given to healthy donors, like you, to increase the number of stem cells in the bloodstream. Usage of G-CSF has been approved by the Department of Health of the Executive Yuan.

Global medium term data(approx. 20 years) reveal that G-CSF presents little negative effect on healthy donors, which include possible cancer occurrence rates and early bone marrow aplasia.

Medical evidence shows that the human bloodstream contains a low concentration of hematopoietic stem cells. Although the number of stem cells is not high enough for the purpose of transplantation, it can be elevated by repeated injections of granulocyte colony stimulating factor(G-CSF for short, also called Filgrastim)which serves to mobilize stem cells from the donor's bone marrow into the peripheral circulation and subsequently collected through apheresis process.

Early studies show that, compared to Bone Marrow Stem Cells donation, healthy donors of PBSC avoid the danger of anesthesia and recover faster.

● Preparatory Regiment Before Collection

1. Complete all testing.
2. Keep public exposure to a minimum for two weeks prior to collection time to help limit possible infections.
3. Maintain good daily dietary and sleeping regiments.
4. Drink milk daily for calcium supplement.
5. Take one filgrastim injection a day, per physician instruction, totaling five injections prior to collection.
6. Under the influence of filgrastim, some donors may experience flu-like symptoms such as bone pain, headache, fatigue or feverishness. Anti-inflammatory medication may be taken to relief these symptoms.


1. Filgrastim Injections Prior to Collection

After you have completed a physical examination and physicians have identified you as an acceptable candidate for PBSC donation, you will be contacted by Tzu Chi volunteers from the Tzu Chi Stem Cells Center to confirm a stem cells collection date.

Before each injection, you will be asked if you experienced any reaction from the previous injection.
Before Filgrastim injection: Three days prior to injection, donor will be asked to provide blood samples for testing. The amount of blood drawn will be around 7-14 cc. Female donors will be asked to have a pregnancy test. The first injection may proceed upon physician’s approval, after reviewing the test results.
First Filgrastim injection: The first Filgrastim injection must be given at a designated hospital or clinic five days before the apheresis procedure. Donor will be observed for 15 minutes for any signs of an allergic reaction. Should any reaction arise, 45 minutes observation will be needed.
Second to fourth injection: Injections are given at a designated hospital or clinic at appointed time.
Before the fourth Filgrastim injection: Donor will provide blood samples for progress checking, so that appropriate adjustment may be provided if needed.
The fifth and final dose of Filgrastim: The fifth dose of Filgrastim is given at a designated collection center on the morning of blood cell donation. The collection will take place in 3-4 hours after the final Filgrastim injection.


2.The PBSC Collection

Peripheral Blood Stem Cells are collected via a process called apheresis. G-CSF injections are required to be administered five days prior to the procedure. It serves to mobilize blood-forming stem cells into the peripheral bloodstream, so that these stem cells can be collected later via centrifugal force in a machine that performs the leukapheresis process.

The collection is performed at a collection center (Tzu Chi Hospital). During apheresis, a needle will be placed into each of your arms. Blood will be removed from a vein in one arm and passed through tubing into a blood cell separator machine. The machine collects blood-forming cells, platelets, and some white blood cells using centrifugal force, while the remainder of blood, plasma and red blood cells, are returned to your body through the other arm. In general, it takes up to two days to complete the process, one collection a day. Each collection time will take 6 to 8 hours. The precise collection volume is determined by the body weight of the recipient. Tzu Chi Stem Cells Center applies the formula: patient’s body weight (kg) x 5 x 10^6. The collected cells are stored at 2 to 6 degree Celsius. They may be stored at room temperature, per hospital request, if the transplantation procedure is to be taken place within 36 hours.

In situations where the donor is not responsive to G-CSF, or that no suitable arm veins are found, or that the donor’s physical condition changes, the donor may be asked to have a central venous line placed (this is a surgical procedure that requires local anesthesia), or to have bone marrow withdrawn from the posterior iliac crests. In either case, consent forms will be needed and physicians will explain the process in further details.

Placing a central venous access catheter is a surgical procedure which requires local anesthesia. You will be asked to review possible risks and to sign an informed consent form. You may reject this request. You may then be asked to make a bone marrow donation and sign such consent forms. In either situation, physicians at Tzu Chi Hospital will explain the procedures in detail. You make the final decision.

Before and after each PBSC collection, you will be asked to provide a 5 cc blood sample for a blood count.

Out of the collected stem cells, 0.5 cc will be kept for various cell count tests and contagious microbe tests. These tests are a valuable part of a successful transplantation. The collected cells will not be used for purposes other than the clinical studies without your consent.

Conditions Unsuitable for Donation
1.If you are pregnant, or are breast feeding: Breast feeding must be stopped throughout the entire duration of G-CSF injections and two days afterwards.
2. If you are allergic to G-CSF or E.coli derived proteins.
3. If you have auto-immune disease: However if you have Hashimoto's or Graves' disease that has been successfully treated and have stopped medication for over a year, you may be allowed to donate.
4. If you have deep venous thrombosis, pulmonary embolism, iritis, or episcleritis.
5. If your platelet count is less than 150,000/mL.
6. If you have been taking Lithium.


3. Clinical Applications of PBSC

Blood stem cells are often used to treat blood or immune system diseases such as leukemia (acute, chronic, lymphocytic, myeloid) and hematopoietic disorders (aplastic anemia, severe combined immunodeficiency). Genetic diseases related to blood generating function and its enzymes such as thallassemia, osteopetrosis, and Gaucher's disease are also treated with PBSCs. Increasing number of solid tumors and autoimmune diseases are being treated with PBSCs. In fact, more and more diseases are being treated with PBSCs.

4. Benefits and Risks of PBSC donation

Early studies show that compared to Bone Marrow Stem Cell donation, the PBSC collection procedure is safer, and that healthy donors of PBSC risk no danger from anesthesia, and show faster recovery. There are reported cases of short-lived side effects (unsure if related to PBSC donation) that are being evaluated which include: swollen spleen, iritis, gout, anaphylactic shock, irregular heart rhythm, and thrombus. There are no evidence that G-CSF increases or decreases chances of possible cancer occurrence and early bone marrow aplasia.

5. Effects of PBSCs to Recipients

Early studies reveal that the recipients of PBSC transplantation, compare that of Bone Marrow Transplantation, endure faster neutrophil and platelet engraftment, less engraftment toxicity, higher disease-free survival rate, and lower relapse rates.

6. Benefits and Risks of PBSC Donation Process

 【Side Effects of Filgrastim】
  Side effects of Filgrastim injection usually disappear one or two days after the last dose of injection. Should you have any questions concerning these descriptions, please contact our center, Tel: 886-3-8561825 Ext: 3518/3519/3216 Fax: 886-3-8574324, E-mail: btcscc@tzuchi.org.tw
1. Possible soreness at the injection site The injection is given just under the skin in the upper arm, the abdominal area or the thigh. (Donor will be observed for 15 minutes for any signs of an allergic reaction. Should any reaction arise, 45 minutes observation will be needed.)
2. Bone and muscle pain Majority of donors experience bone pain. Doctors may prescribe medication or reduce Filgrastim dosage to relieve the symptom. Should the symptom persist after medication, please contact the medical professional who administered Filgrastim injections, or administration staff at Tzu Chi Stem Cells Center.(Tel: 886-3-8561825 Ext: 3518/3519/3216 Fax: 886-3-8574324, E-mail: btcscc@tzuchi.org.tw
3. Lower than average number of platelets Before the collection of PBSCs, your platelet count will be evaluated. Should the number of platelets be lower than 80% of the minimum average rate, your physician will discuss a few possible solutions with you based upon the platelet rate:

Monitor the number of platelets throughout the duration of collection process.
Shorten the collection time.
Delay one day for collection.
Cancel PBSCs donation.
Consider bone marrow donation.
Consider other possible solutions.

During PBSC collection, platelets will also be collected, causing a sudden dropping of platelet count in your system, which decreases the normal blood clotting process. Therefore it is very important that you do not take aspirin or product that contains aspirin throughout the entire duration of G-CSF injections and 14 days after PBSCs collections.

4. Soreness under lower left rib cage If you detect pain in this area, please contact immediately the physician or member of the administration staff at Tzu Chi Stem Cells Center.(Tel: 886-3-8561825 Ext: 3518/3519/3216 Fax: 886-3-8574324, E-mail: btcscc@tzuchi.org.tw)This may be swelling or bleeding of the spleen, a rare side effect (one in ten thousandth) of Filgrastim injection.
5. Female donors of child-bearing age must take a pregnancy test before Filgrastim injections. Filgrastim may affect the development of the fetus. If you are a breast feeding female, you are not allowed to take Filgrastim injections. Please be certain that there is no possibility of nursing babies, or getting pregnant, throughout the injection period and 48 hours thereafter.
6. Other common side effects include headache, muscle pain, shiver, nausea, vomit, night sweats, sleeplessness. These side effects usually disappear 2-3 days after the last dose of the drug.
7. Some allergic reactions may occur such as rapid heart rate, dizziness, shortness of breath, itchiness or skin rash.
  Supplementary Table. Selected studies about the side effects during hematopoietic stem cell mobilization by G-CSF.
  Japan Canada America Spain Italy America Taiwan
  Murata M et al.[1](n=94) Karlsson L et al.[2](n=116) Horowitz MM et al.[3](n=1080) de la Rubia J et al.[4](n=1538) Martino M et al.[5](n=184) Pulsipher MA et al.[6](n=2408) Chen SH et al.[7](n=476)
Fatigue 33.0% 49% 49% 6% 19.0% 69.8% 44.1%
Nausea/anorexia 10.6% 20% 11% 5% 12.0% 28.1% 13.9%
Vomiting 10.6% 20% 2% -- -- 5.4% 5.9%
Bone pain 71.3% 68% -- 90% 71.2% 82.7% 64.9%
Myalgia/arthralgia --   54% 90% -- 74.1% 58.2%
Headache 27.7% 70% 52% 33% 27.7% 72.8% 33.0%
Sweats -- -- 14% 2.2% -- 21.8% 9.5%
Fever 2.1% 10% 6% 6% 5.4% 15.0% 9.5%
Chills -- 10% 6% -- -- 14.1% 5.3%
Insomnia 13.8% -- 28% 1.3% 22.3% 43.3% 16.6%

1. Murata M, Harada M, Kato S, et al. Peripheral blood stem cell mobilization and apheresis: analysis of adverse events in 94 normal donors. Bone Marrow Transplant 1999;24:1065-1071.
2. Karlsson L, Quinlan D, Guo D, et al. Mobilized blood cells vs bone marrow harvest: experience compared in 171 donors with particular reference to pain and fatigue. Bone Marrow Transplant 2004;33:709-713.
3. Horowitz MM, Confer DL. Evaluation of hematopoietic stem cell donors. Hematology Am Soc Hematol Educ Program 2005:469-475.
4. de la Rubia J, de Arriba F, Arbona C, et al. Follow-up of healthy donors receiving granulocyte colony-stimulating factor for peripheral blood progenitor cell mobilization and collection. Results of the Spanish Donor Registry. Haematologica 2008;93:735-740.
5. Martino M, Console G, Dattola A, et al. Short and long-term safety of lenograstim administration in healthy peripheral haematopoietic progenitor cell donors: a single centre experience. Bone Marrow Transplant 2009;44:163-168.
6. Pulsipher MA, Chitphakdithai P, Miller JP, et al. Adverse events among 2408 unrelated donors of peripheral blood stem cells: results of a prospective trial from the National Marrow Donor Program. Blood 2009;113:3604-3611.
7. Chen SH, Yang SH, Chu SC, et al.. The role of donor characteristics and post-granulocyte colony-stimulating factor white blood cell counts in predicting the adverse events and yields of stem cell mobilization. Int J Hematol. 2011 May;93(5):652-9.
 【Common side effects of the PBSC apheresis procedure】
  During apheresis, a needle will be placed into each of your arms. Blood will be removed from a vein in one arm and passed through tubing into a blood cell separator machine. The machine collects blood-forming cells, platelets, and some white blood cells using centrifugal force, while the remainder of blood, plasma and red blood cells, are returned to your body through the other arm.
Bruising or soreness at needle site may occur, but rarely heavy bleeding.
Loss of blood for about 100 cc, in very rare chance, if the apheresis machine breaks down.
Numbness or tingling sensation around the mounth, fingers or toes due to decreased calcium ions in your system. This is caused by an anticoagulant (blood-thinner) used to prevent clotting during the apheresis procedure. If you experience these symptoms, you must notify the medical professional performing the procedure. These symptoms are easily treated by slowing down the procedure, or giving the donor calcium. If not treated, it may lead to muscle cramps.
Slight headache, vomit, dizziness, or chill are other common side effects due to blood being circulated outside of your body. These symptoms may be improved by using blankets or heat lamp.
Low platelet count caused by apheresis process. Should the platelet count be too low after the first collection, the second collection may be canceled. Generally, the platelet count will return to normal 2 to 4 weeks after the donation.
 【Injury During PBSC Donation Procedure】
  The possibility of injury occurres during the donation procedure is very rare. If any injury should happened, the hospital performing the procedure and Tzu Chi Stem Cells Center will provide necessary medical care.


7.Post-donation Care

(1) Return to your ward and wait for the physician’s clearance to leave.
(2) Maintain good hygiene around the needle wounds.
(3) Take protein and calcium rich food daily, such as tofu and milk.
(4) Get plenty of rest and sleep.
(5) Bone pain and fatigue should disappear one or two days after the last dose of filgrastim injection.
(6) Do not take aspirin or products that contain aspirin.
(7) Take caution to avoid collision.
(8) Contact our center immediately should any symptoms persist after taking treatment.


8. Steps of PBSC Donation Procedure

The donation procedure from G-CSF injection, stem cells collection, to post-donation follow-ups are listed as follows:
Reaction Evaluation
Filgrastim Injections
PBSCs Collections
Blood Sampling
1.Pre-injection Blood Sampling
2.First Day, G-CSF Injection
3.Second Day, G-CSF Injection
4.Third Day, G-CSF Injection
5.Fourth Day, G-CSF Injection
6.Fifth Day, G-CSF Injection and First Collection
7.Sixth Day and Second Collection**
8.Post-Donation Same Day Follow-up
9.One-Week Post-Donation Follow-up**
10.One-Month Post Donation Follow-up
11.Three-Month Post Donation Follow-up (Questionnaire)
12.One-Year Post-Donation Follow-up
13.Post-Donation yearly Follow-up (up till the tenth year)
* Determined by the physician based upon the collection result.
** If the donor is not fully recovered one week after the donation, the follow-up will continue on a weekly basis.

Update: Oct. 2009

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