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Application of Cord Blood Platelet Gel (CBPG) for the treatment of non-healing skin ulcers due to the cutaneous chronic GVHD

Safety and Effectiveness evaluation of Allogeneic Cord Blood Platelet Gel (CBPG) for the treatment of non-healing skin ulcers/erosion due to the cutaneous chronic GVHD: A Randomize Clinical Trial (Pilot study)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190101042197N1
Enrollment
15
Registered
2020-08-24
Start date
2020-07-22
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unhealed skin ulcers in patients with chronic GVHD skin complications. Chronic graft-versus-host disease

Interventions

Intervention 1: Intervention group: Platelet gel from allogeneic cord blood. Cord blood is taken from the umbilical cord blood bank of Bon Yakhte Royan Co. and then in the clean room of the Pediatric

Sponsors

Royan Stem cell Technology Co.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 15 Years

Inclusion criteria

Inclusion criteria: Existence of chronic GvHD criteria after allogeneic hematopoietic stem cell transplantation Wounds in the upper, lower and trunk Wound surface area more than 2 cm2 and less than 5 cm2 with at least 6 weeks durability Wound grading is 2 and 3. Minimum age one year and maximum 15 years

Exclusion criteria

Exclusion criteria: Other diseases such as diabetes, allergies, coagulopathies or underlying diseases that involve the skin Wounds are small (less than 1 cm) or very large (more than 5 cm) Wound grade is 1 or 4. Lesions on the face and neck

Design outcomes

Primary

MeasureTime frame
Reduce wound surface area. Timepoint: At the beginning of the study and 7, 15 and 30 days after the start. Method of measurement: Direct view.;Causes severe allergic reactions. Timepoint: 1, 3 and 7 days after the intervention. Method of measurement: Direct view.;Infection. Timepoint: One week after intervention. Method of measurement: Sampling.;Reduced pain. Timepoint: One month after intervention. Method of measurement: direct examination.

Secondary

MeasureTime frame
Normal physical activity. Timepoint: 6 month after intervention. Method of measurement: Direct examination and observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Rashin Mohseni

Tehran University of Medical Sciences

rashin_mohseni@yahoo.com+98 21 6694 8444

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 8, 2026