A clinical study of efficacy and safety for PTH recombinant plasmid and PTH rhMSC therapy in the patients with hypoparathyroidism

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100041719

Enrollment

Unknown

Registered

2021-01-02

Start date

2021-01-04

Completion date

Unknown

Last updated

2021-03-22

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

Conditions

hypoparathyroidism

Interventions

PTH naked plasmid-1:PTH naked plasmid 500 µg,/kg,ih+Calcium agent

PTH naked plasmid-2:PTH naked plasmid 300 µg,/kg,ih+Calcium agent

PTH naked plasmid-3:PTH naked plasmid 100 µg,/kg,ih+Calcium agent

PTH-rhMSC-1:PTH-rhMSC 10^6/ kg,ih+Calcium agent

PTH-rhMSC-2:PTH-rhMSC 10^7/ kg,ih+Calcium agent

PTH-rhMSC-3:PTH-rhMSC 10^8/ kg,ih+Calcium agent

Calcium agent therapy control:Calcium +Calcitriol

pcDNA3.1 control:pcDNA3.1 +Calcium agent

uninfected MSC control:uninfected MSC+Calcium agent

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female aged between 18 and 65 years; 2. The parathyroid gland is injured by surgery, which leads to the hypothyroidism; 3. Idiopathic hypothyroidism; 4. The concentration of parathyroid hormone in blood is lower than the lower limit of normal physiological value; 5. Clinical manifestations caused by hypocalcemia; 6. Normal function of heart, kidney and liver; 7. Sign informed consent and be willing to cooperate with treatment actively.

Exclusion criteria

Exclusion criteria: 1. Parathyroid gland metastases; 2. Drug induced hypothyroidism (chemotherapy); 3. Congenital hypoplasia of thymus with absence of parathyroid gland; 4. Hypercalcemia; 5. Iron deposition; 6. Hemochromatosis; 7. Hepatolenticular degeneration; 8. Liver and kidney dysfunction; 9. Advanced stage of tumor; 10. Pregnancy and lactation; 11. There was an unexplained increase of alkaline phosphatase; 12. Other bone metabolic diseases (including hyperparathyroidism and Paget's disease) except primary osteoporosis and glucocorticoid induced osteoporosis; 13. Patients who have received external irradiation or bone implantation radiotherapy before; 14. Any clinical related diseases that may affect the study participation and / or results; 15. Has participated in other clinical trials; 16. Patients who the researchers believe are unwilling or unable to follow the study.

Design outcomes

Primary

Measure	Time frame
parathyroid hormone;Serum total calcium;Free serum calcium;Serum free phosphorus;serum uric acid;PTH antibody;	—

Secondary

Measure	Time frame
Calcitonin;Serum magnesium;	—

Countries

China

Contacts

Public ContactZhao Zhenlin

zhaozl2006@163.com+86 13828895409

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026