Clinical results

More than 5,000 patients have so far undergone kidney transplants using Glycosorb® ABO. A number of independent studies from different countries show that the results are excellent even over a longer follow-up period and that they are equivalent to the results of blood group compatible kidney transplants from living related donors. Overall, excellent clinical results have been presented at several international transplantation congresses and in more than 60 scientific articles in reputable international medical journals.

Follow-up of 200 transplants

Glycosorb® ABO has been used in Sweden since 2001 and in September 2012 Läkartidningen (Journal of the Swedish Medical Association) published a report on the overall clinical experience in the country. The authors were Professor Gunnar Tydén, Karolinska University Hospital, Chief Physician Gunnela Nordén, Sahlgrenska University Hospital, Chief Physician Ali-Reza Biglarnia, Academic Hospital, and Chief Physician Peter Björk, Skåne University Hospital. The authors conclude that more than 200 ABO-incompatible kidney transplants from living donors were performed in Sweden during the period 2001-2012 with results that are at least as good as in transplants with ABO-compatible living donors. Referring to the fact that the first transplants were carried out in 2001, it is stated that they now also have good experience of long-term results.

 

Example

Results: ABO-incompatible group
n=40
ABO-compatible group
n=43
  • Median follow-up time:
39 months 19 months
  • Patient survival:
98 % 98 %
  • Death censored graft survival
100 % 93 %

Graft function, rejections, infections: No significant differences between the two groups

”Long-term outcome of ABO-incompatible living donor kidney transplantation based on antigen-specific desensitization.”
J. Wilpert et al, Nephrol Dial Transplant 2010

 

Examples of clinical experience with Glycosorb® ABO

More than 5,000 patients in about 30 countries have undergone blood group incompatible transplants using Glycosorb® ABO. Clinical experience shows that the results of the transplants have also been excellent over a longer follow-up period and are equivalent to the results of blood group compatible transplants.

Features Comments
Removal of specific blood group-antibodies
    • Glycosorb® ABO specifically removes the blood group A/B antibodies in blood plasma¹.
    • Does not affect other antibodies, coagulation factors or other components in the blood².
High safety level
  • No need for replacement fluids (blood plasma or chemical solutions).
  • Specific treatment, little effect on the patient’s total antibody levels, coagulation proteins or other plasma proteins, even when treating several plasma volumes.
  • Reduces the risk of infections, bleeding and other side-effects compared with alternative unspecific methods.
Effective treatment
  • Proven to effectively lower the levels of blood group-antibodies (anti-A/B antibody titres, RBC).
  • For example, it has been shown that the patient titres can be reduced from 1:512 to 1:8 after one treatment, by treating several patient plasma volumes.
  • The anti-A/B antibody titre (RBC) has been shown repeatedly to be 1:0 or 1:1 in plasma immediately after the column, even with high levels (anti-A/B titres ≥1:256) before the column.
Continuously product improvement
  • Glycosorb® ABO is today an established and verified medical device.
  • The product is considerably more effective today compared with the launch, leading to fewer treatments per patient.
Blood group incompatible kidney transplants from living donors
  • Glycosorb® ABO has been used to treat adult and pediatric patients undergoing ABO incompatible transplantation since 2001
  • The short- and long-term data are excellent with 11-year-follow-up-data for ABO-incompatible Living Donor Kidney Transplants (LDKT) with Glycosorb® ABO similar to data for ABO-compatible LDKT.
Blood group incompatible liver -, heart -, and lung – transplants
  • Glycosorb® ABO has been used to effectively lower the levels of anti-A/B antibodies in acute cases when the levels of anti-A/B antibodies have risen dramatically after kidney, liver, heart and lung transplantation and this has successfully prevented acute rejection.
  • Glycosorb® ABO is also incorporated into the cardiopulmonary bypass circuit (CPB-circuit), to enable ABO-incompatible pediatric heart transplants.
Stem cell transplants
  • Glycosorb® ABO has been used successfully in blood group incompatible stem cell transplants.
  • Prevents, for example, haemolysis and anaemia and potentially avoids multiple transfusions.

¹ It should be noted that Glycosorb®-ABO reduces anti-A/B antibodies belonging to the different subclasses of IgG (IgG1, IgG2, IgG3 and IgG4) and also those anti-A/B antibodies that belong to IgM. In contrast, there is no significant effect on the total quantity of antibodies as anti-A/B antibodies only constitute a minor proportion of the total antibody content in plasma. This has been shown repeatedly in many different plasmas (Please contact us for further information). This distinguishes Glycosorb®-ABO from other columns that are selective for removal of IgG antibodies (protein-, peptide- or antibody-based columns). These latter columns are developed for and normally used to reduce the total antibody quantity in the patient, for example in autoimmune conditions. It has been recently shown that the use of these latter columns, even after multiple separate treatments and 99 % removal of IgG, still requires additional plasma exchange treatments to achieve low anti-A/B titers (Becker et al, Transplantation. 2015 May 16). Repeated plasma exchange treatments have been shown to give several side effects: Increased risks of early wound infections, pneumonia and UTIs, due to hypogammaglobulinemia and hypocomplementemia, and increased bleeding risk due to reduction of coagulation factors, as well as thrombocytopenia due to loss of platelets in the discarded plasma and dilutional effects of replacement fluids (K. L. Lentine, D. Axelrod, C. Klein et al. Transplantation vol 98, 2014 pp. 54-65).

² Re-use of the same unit has shown that it may cause unspecific effects, for example allergic reactions and reduction of the total antibody content in plasma, which is not seen on single-use.

Scheelevägen 27 | SE-223 63 Lund, Sweden

Phone: +46 46 286 52 30  | Fax: +46 46-286 52 39
E-mail: info@glycorex.com

Org.nr: 556519-7372

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