Effect of Cell Surface Markers and Lymphoid Cell Distribution on the Arterial Tissue Repair (ECLAR)

Injury of Radial Artery at Wrist and Hand Level Clinical Trial

— ECLAR  

Official title:

Effect of Cell Surface Markers Like CD 34 - CD 133 - CD 309 and Lymphoid Cell Distribution on the Wrist Laceration With Radial or Ulnar Arterial Tissue Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02421081
• Other study ID #: IKCD
• Status: Recruiting
• Phase: N/A
• First received: March 14, 2015
• Last updated: October 10, 2016
• Start date: August 2014
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: TC Erciyes University
• Contact: Ali Eray GUNAY, MD,resident
• Phone: +905556493401
• Email: alieraygunay[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey : Erciyes University Clinical Research Ethics CommitteeTurkey : Erciyes University Department of Scientific Research Project
• Study type: Interventional

Clinical Trial Summary

The radial and ulnar artery injuries related with the wrist cut are frequently encountered. There are many factors which are effective on the improvement of these arterial structures was repaired with microsurgical techniques. Recently has begun to focus on neointimal thickening and endothelialization of the role in vascular healing and maturation made on histopathological study. In this study, the radial and ulnar artery laceration repair healing with the microsurgical anastomosis methods on blood CD34, CD133 and CD309 levels of the effect of the distribution of lymphoid cells has been investigated. The investigators think that; thus by demonstrating the positive impact that may arise; autologous endothelial progenitor cells which are obtained in patients; continuation of anastomotic patency undergoing coronary by-pass or the in hemodialysis patients with arteriovenous fistula; also ensuring the re-flow in patients with acute and chronic peripheral arterial occlusion. The investigators believe could be used for the reimplanted tissue in the limb breakage ensuring that survive.

Description:

The radial and ulnar arteries cuts that need to be urgently repaired using microsurgical techniques; after treatment failure rate is quite high among the injured. When straight cut repaired with microsurgical instruments under the microscope cut properly; can be obtained close to excellent results. However, there are many factors that impact on the arterial healing. Hypertension, hypotension, age, diabetes mellitus, obesity and female gender has negative effects on the vascular healing. In recent years, positive effects of endothelialization begun to focus on the improvement; and has been shown to endothelialization on the hematopoietic stem cells and endothelial progenitor cells CD34 and CD133 cd309 is effective. CD34 is a type 1 transmembrane protein and is known as the stem cell marker. Proliferative cells and endothelial stem cells play an important role still in the healing process after vascular incisions. These include CD133 (haematopoietic progenitor cells) and CD309 (Vasculoendotelial Growth Factor Receptor 2) is also believed to be effective. These stem cells and proliferating endothelial cells is called collectively endothelial proliferative cells (EPC). Griese et al in a study had been done on rabbits; autologous endothelial cells, obtained from peripheral blood with immunohistochemical methods, were transplanted after carotid artery intimal injury experimentally.The EPC-treated group was observed that increased endothelialization and significantly reduced neointimal hyperplasia, compared to the control group. Kawamoto et al in their study ex vivo; endothelial progenitor cells in the myocardial ischemic group, has been shown to have positive impact on the preservation of left ventricular function. In another clinical study in patients with peripheral arterial disease with ischemic limbs; increase of oxygen carried in the extremities in the study group, decrease in rest pain, increase in walk distance and had an increase in ankle-brachial index.

In the investigators study on the vessel laceration, such as CD 34, CD133 and CD309 endothelial progenitor cells and stem cells in the blood levels will show whether the effects on vascular healing. Results to be obtained; frequently encountered and the relatively high treatment costs and lead to the loss also great labor; myocardial infarction, peripheral arterial disease, ensuring the fistula opening in chronic dialysis patients, provision of limb preservation and vitality of limb replantation will open up new horizons.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients will be chosen

1. Older from 18 year

2. Don't use any medicine

Exclusion Criteria:

1. younger from 18 years

2. Having another illness

3. Using medicine

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Injury of Radial Artery at Wrist and Hand Level
• Injury; Ulnar Artery, Hand and Wrist
• Wounds and Injuries

Intervention

Procedure:
• vessel microsurgery
That is a surgery ro repair artery laceration.
• tendon repair
That is a surgery ro repair tendon cut.
• nerve microsurgery
That is a surgery ro repair median/ ulnar/ radial nerve cut.

Locations

Country	Name	City	State
Turkey	Erciyes University Faculty of Medicine	Melikgazi	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. Review. — View Citation

Dixon BS, Novak L, Fangman J. Hemodialysis vascular access survival: upper-arm native arteriovenous fistula. Am J Kidney Dis. 2002 Jan;39(1):92-101. — View Citation

Glagov S, Zarins C, Giddens DP, Ku DN. Hemodynamics and atherosclerosis. Insights and perspectives gained from studies of human arteries. Arch Pathol Lab Med. 1988 Oct;112(10):1018-31. Review. — View Citation

Griese DP, Ehsan A, Melo LG, Kong D, Zhang L, Mann MJ, Pratt RE, Mulligan RC, Dzau VJ. Isolation and transplantation of autologous circulating endothelial cells into denuded vessels and prosthetic grafts: implications for cell-based vascular therapy. Circ — View Citation

Guzman RJ, Abe K, Zarins CK. Flow-induced arterial enlargement is inhibited by suppression of nitric oxide synthase activity in vivo. Surgery. 1997 Aug;122(2):273-9; discussion 279-80. — View Citation

Kawamoto A, Gwon HC, Iwaguro H, Yamaguchi JI, Uchida S, Masuda H, Silver M, Ma H, Kearney M, Isner JM, Asahara T. Therapeutic potential of ex vivo expanded endothelial progenitor cells for myocardial ischemia. Circulation. 2001 Feb 6;103(5):634-7. — View Citation

Mattsson EJ, Kohler TR, Vergel SM, Clowes AW. Increased blood flow induces regression of intimal hyperplasia. Arterioscler Thromb Vasc Biol. 1997 Oct;17(10):2245-9. — View Citation

Szmitko PE, Fedak PW, Weisel RD, Stewart DJ, Kutryk MJ, Verma S. Endothelial progenitor cells: new hope for a broken heart. Circulation. 2003 Jun 24;107(24):3093-100. Review. — View Citation

Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogene — View Citation

Werner N, Junk S, Laufs U, Link A, Walenta K, Bohm M, Nickenig G. Intravenous transfusion of endothelial progenitor cells reduces neointima formation after vascular injury. Circ Res. 2003 Jul 25;93(2):e17-24. Epub 2003 Jun 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	flow velocity of vessel measure with doppler ultrasonography (cm/sn)	the patients will be divided 4 groups with flow velocity	flow velocity will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery	Yes
Primary	CD 34 - 133 - 309 measurement with immunohistochemical techniques (piece)	CD 34 - 133 - 309 levels will be compared between groups	6 hours after trauma	No
Primary	vessel diameter measure with doppler ultrasonography (cm)	the patients will be divided 4 groups with vessel diameter	vessel diameter will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery	Yes