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Clinical study on safety assessment of PRP therapy for development dysplasia of hip(PRP for hip dysplasia) (PRP for hip dysplasia)

Clinical study on safety assessment of PRP therapy for development dysplasia of hip(PRP for hip dysplasia) (PRP for hip dysplasia)

kazuhisa TAKAHASHI

July. 26, 2020

1

68 yrs old female.

Planned as a safety study,and perfomred for one case. However,the participant withdrew of the consent.

No adverse event.

Primary endpoint : No adverse event such as infection was not observed in one patient. Secondary endpoint : pain scale and hip fucntion was not changed from pre PRP injection to 2 weeks after PRP injection.

According to the experience in one patient in this study and the evidences reported recently,it was considered that the PRP injection for patient of hip dysplasia with endstage osteoarthritis was not scientifically validated. Thereby,this resarech was cancelled.

Mar. 31, 2023

https://jrct.mhlw.go.jp/latest-detail/jRCTb030190271

Homma Yasuhiro

Juntendo Hospital, Juntendo university school of medicine

3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan

yhomma@juntendo.ac.jp

Masubuchi Yosuke

Juntendo university

2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan

+81-3-3814-5672

y-masubuchi@juntendo.ac.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1.Patients who have symptoms for more than 3 months
2.Patients who have continued pain even after taking NSAIDs for 6 week or more and who can not use NSAIDs for asthma and digestive tract ulcer
3. More than 20 years old
4. Other , patients who the doctor has determined that it is suitable for this clinical study

1.Patients with a history of hip surgery
2. Patients with abnormal platelet counts in peripheral blood
3.Person who smokes a lot (Brinkmanindex>600)
4. Treatment with anticoagulants(Warfarin)
5. Uncontrolled diabetes mellitus : HbA1c not lower than 9.0% according to latest laboratory data obtained within 14 days before registration
6. Patients with malignancy
7. Patients less than 6 months after onset of cardiac infarction or cerebral infarction
8. Predictive survival period is less
than 1 year
9. Active infectious disease (HBV, HCV, HTLV-1, HIV, syphilis)
10.Dialysis patients
11. Compromised host
12.Requiring continued use of oral corticosteroid therapy
13. Less than 20 years old
14.Doctor has determined that it is not suitable for this clinical study

Both

Patients who is diagnosed Hip osteoarthritis (Kellgren and Lawrence grade 4) due to development dysp

administration of cell processing products.

safety

efficacy

Complete

+81-3-5803-4162

Mar. 14, 2019